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News

Join us at the 2021 RAPS U.S. Convergence

30 August 2021 It is that time of year again for RAPS Convergence and we cannot wait to join the largest annual gathering of regulatory professionals from around the world. The conference will be held virtually this year from 12-15 September 2021 and we will be joining in the fun with a Q&A style speaking session and a booth featuring premium expert content from this year. Learn more about our session, booth, and giveaway below and we hope to see you at RAPS Convergence in September!
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Webinars

RAPS Webcast: PMCF User Feedback Surveys

Update: the RAPS + RQM+ webcast is now available on demand here. Understand the ins and outs of PMCF user feedback surveys by registering for two upcoming and free RQM+ webinars: April 27 – PMCF User Feedback Surveys: Practical solutions for leveraging user feedback surveys as PMCF activities under the EU MDR (60 minutes) (register here) May 18 – PMCF User Feedback Surveys: Practical Solutions, Lessons Learned, and Processes for Success (features activity to develop a survey in real-time, 90 minutes, 1.5 RAC credits) (now available on demand)
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Webinars

PMCF User Feedback Surveys

In this webinar we will provide practical solutions for leveraging user feedback surveys as PMCF activities under the EU MDR, presented by former notified body leadership and PMCF subject matter experts.
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Webinars

Best Practices for Scientific Database Searching

This on-demand webinar will address best practices in scientific database search techniques that can be applied in the performance of a clinical evaluation.
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Webinars

Integrating Risk and Complaint Management

Having strong integrated complaint and risk management processes is about more than just compliance. Watch this webinar and learn critical strategies and tactics for success. As with every R&Q webinar, all registrants will receive access to the slides and recording.
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Webinars

Program Management for IVDR and EU MDR

Whether you’re just starting to plan your IVDR program (or not sleeping well because you haven’t started yet) or well into EU MDR but ready to plan post-market surveillance activities, our September webinar will be helpful. All registrants will receive access to the slides and recording.
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News

Roundup: R&Q at the 2020 RAPS Convergence

R&Q is counting down the days until we can join the RAPS community at the virtual RAPS Convergence 2020 on 13-16 September 2020. As many of you know, the Convergence is the largest annual gathering of regulatory professionals from around the world. While we'll miss interacting with everyone onsite and having fun at our exhibit booth, we're embracing this year's online format and will be doing everything we can to communicate our team's energy and expertise virtually. Thankfully, we have two can't-miss speaking sessions to help us do that!  
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News | Live!

Ranked: The most popular on-demand panel discussions from R&Q

Note: A version of this post was initially published for the flagship online publication of RAPS, Regulatory Focus™ In an effort to further support the medical device industry during the COVID-19 pandemic, we've been spreading love more than ever in one of the best ways we know how: free industry-leading education. In April, R&Q debuted a new live show: DEVICE L❤️VE Live! Webcams in, presentation slides out: The biweekly panel discussions focus on answering questions, engaging in friendly debate, sharing some laughs, and always, always... offering solutions and value. In hopes that you see a topic that interests you and aligns with your objectives, we've ranked the most popular episodes of the show to this point below. Additionally, these and all shows are also available via our Device Love Podcast.
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Webinars

Economic Operators: EU MDR and IVDR Requirements

In our August 2020 webinar you'll learn about the EU MDR and IVDR requirements for economic operators.
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Webinars

PMCF Plans

In this on-demand webinar originally presented in July 2020, find out how to create detailed, compliant, and business-balanced PMCF plans.
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Webinars

Developing an FDA Regulatory Strategy (Part 2)

A definitive guide for entering the US market.
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Webinars

Case Studies of MDD and MDR Audit Findings... and Lessons Learned

On-Demand - A webinar entirely dedicated to case studies.
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Live!

DEVICE L❤️VE Live! #5 — 5/14/20

Chatting with Former FDA and Notified Body Representatives
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Webinars

FDA Emergency Use Authorization (EUA) and EU MDR Article 59

26 May 2020 - Processes, tips, and lessons learned.
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News | Events | Live!

Join Us Weekly — Announcing DEVICE L❤️VE Live!

The current pandemic is challenging for everyone to varying degrees. R&Q has the utmost respect, appreciation, and love for healthcare workers and all frontline workers across the globe. Our mission from the start has been to improve people's lives and our announcement today has regulatory and quality medical device professionals in mind. There is no better time than now for all of us in and connected to the healthcare industry to be at our best for patients requiring medical care and the healthcare workers providing it. Along with rallying around one another for support, sharing and discussing the latest industry news, regulation changes, pressure points, and potential solutions to problems can be invaluable for us all. Actual solutions are obviously important and our company name isn't Regulatory & Quality Solutions by chance! Those of us not on the frontlines and practicing social distancing (the majority of regulatory and quality pros we know) are also craving connection. FaceTime, Zoom, Houseparty, or whatever your app of choice for connecting with family and friends is great, but what about all those cancelled conferences and networking events? We still need to connect with and learn from each other professionally. For all of those reasons and following in the footsteps of our monthly webinars (which will continue), we're excited to announce a new live and interactive weekly show: DEVICE L❤️VE Live! Show #1 will be next Friday, April 17th. How will it go? Each show will center around a specific newsworthy topic and bring together experienced thought leaders on camera to discuss it. For example, next week we'll discuss moving medical device manufacturing out of China. Weekly topics will be chosen based on what challenges our clients are facing and what our own experts are reading about. The sessions will depend on your questions. We'll bring some client questions to the table and some of our own, but the direction each show takes will be dictated by you. Ask questions live and if fellow attendees want to see it answered by our panelists, they'll be able to easily upvote it. This brings the most popular questions to the top of the list for the moderator to ask the panelists about. Read on for more information on next week's show and subscribe to our blog to learn of the weekly topics.    
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Webinars

RAPS Webcast: PMS Requirements of the EU MDR

  Note: this webcast is now available on demand. R&Q is a Premium Solutions Partner of the Regulatory Affairs Professionals Society (RAPS) and on Wednesday, April 15th, we're joining forces to offer up a premium live webcast. Attendees will earn 1.5 RAC credits and the event is free. R&Q Executive Director of Regulatory and Quality Consulting Services, Nancy Morrison, will be presenting PMS Requirements of the EU MDR: Implementation Challenges and Solutions. This webinar will be an extended, enhanced, and more up-to-date version of R&Q's own February 2020 webinar. An hour and a half has been allotted and Nancy will be taking live questions. This is your chance to get difference-making information from one of the industry's utmost thought leaders and apply it to your own organization.
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News | Webinars

Q&A: PMS Requirements of the EU MDR

In February – just before COVID-19 began to seriously impact those of us in the United States – R&Q Executive Director of Regulatory & Quality Consulting Services, Nancy Morrison, presented the webinar PMS Requirements of the EU MDR: Implementation Challenges and Solutions. We received a ton of excellent questions during that webinar and in this blog post, we'd like to publicly share our answers to many of them. We hope you find them helpful! If you haven't seen this webinar yet, here's a link where you can sign up to view the on-demand version (and download the slides). If you have specific questions in this area, please contact us.
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Webinars

Structuring PERs under IVDR

Whether you are interested in improved strategies for completing PERs or effectively completing your first PER, our April 2020 webinar can act as a critical guide.
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Webinars

EU MDR Audits

Preparing, managing and responding to nonconformances.
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News | Webinars

Q&A: Developing an FDA Regulatory Strategy

R&Q's first webinar of 2020 was the first in a two-part series on bringing your medical device to market in the United States. Part one addressed Class I and Class II devices, while part two (TBA in the spring) will cover Class III devices. The questions we received related to January's webinar were phenomenal. In this blog post, we share some answers to those questions and hope you find them helpful. Here's a link where you can register for the on-demand webinar (and download the slides) if you have yet to do so.
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Webinars

PMS Requirements of the EU MDR

Our February 2020 webinar will help you optimize every element of PMS/PMCF as it relates to the EU MDR at your organization.
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Webinars

Developing an FDA Regulatory Strategy

Our January 2020 webinar is designed to help you create a comprehensive regulatory strategy that enables you to successfully enter the US market.
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News

Announcing R&Q's new Vice President of Technical Services, Ralph Asencio

Regulatory & Quality Solutions (R&Q) is absolutely delighted to announce Ralph Asencio as Vice President of Technical Services! R&Q has plenty to be thankful for in 2019. It's been an incredible year for a multitude of reasons, one of which has been the addition of key technical experts and leadership with knowledge and skills spanning across all of our service offerings. After more than 20 years with BSI, Dr. Ibim Tariah joined R&Q as Vice President of EU MDR and IVDR Consulting Services. Early in the year, Ron Sills joined R&Q after spending more than seven years as TÜV Rheinland North America's Lead Auditor of Medical. These are just a couple examples of many, and we're proud to add Ralph's name to the list. Ralph's addition helps R&Q expand our technical service offerings, build more strategic partnerships with core clients, expand regulatory intelligence and education offerings to clients, and provide technical guidance and business leadership across the board. R&Q has never been more primed to service our clients. Read on to learn more about Ralph's background (including his experience with global organizations in complex and challenging situations), his new role at R&Q, how he will benefit our clients, and why he's excited to join the team!
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Events

DIA Combination Products Conference – EU MDR Impact to Drug Delivery Devices

October 29-30, 2019 — Bethesda, MD
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Events

FDA Inspections Summit – EU MDR: The Final Push [Panel]

October 24-25, 2019 — Bethesda, MD
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Webinars

Solving the EU MDR Labeling Puzzle

Our December webinar will help you understand and act on requirements.
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Webinars

Strategies for Successful IVDR Implementation

Our November 2019 webinar looked at how to assess products and more.
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Webinars

FDA Updates

Our October 2019 webinar highlighted key areas of change related to the FDA.
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News

Ibim Tariah Joins R&Q

 
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Events

The MedTech Conference (AdvaMed) – CER Panel Discussion

September 23-25, 2019 — Boston, MA
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Events

FDA MedTech Regulatory Forum – EU MDR Panel

August 22, 2019 — Akron, OH
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Events

DeviceTalks Minnesota – Fireside Chat (EU MDR)

September 9-10, 2019 — Minneapolis, MN
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News

Q&A: Integrating CERs and Post-Market Surveillance

While we're in the midst of taking the summer off from webinars (see you in the fall!) and excitedly preparing for our CER Virtual Workshop in September, we did have our most popular and best-reviewed webinar ever in May: Integrating CERs and Post-Market Surveillance. The webinar covered how data inputs and outputs of clinical, regulatory, and post-market documentation interrelate, and must be included in a variety of plans and reports per new requirements detailed in the EU MDR. We introduced a new way to think about categorizing the abundance of information ("data packets"), which based on webinar feedback, resonated with the vast majority of those who viewed the webinar.
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Events

RAPS Regulatory Convergence – EU MDR Panel Discussion

September 21-24, 2019 — Philadelphia, PA
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Events | Webinars

CER Virtual Workshop

Case studies and tips for EU MDR compliant CERS.
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Webinars

Integrating CERs and Post-Market Surveillance

Data inputs, outputs, and everything in between.
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News

That's a wrap! A recap of our Advanced EU MDR and CER Workshops and what to do if you missed them.

In March R&Q partnered with the Medical Alley Association in Minneapolis and MassMEDIC in Boston to offer industry-leading educational workshops on the EU MDR and CERs. R&Q recruited top industry experts, including representation from notified bodies BSI and GMED North America, along with senior leaders from medical device companies 3M, Abbott, BD, and Boston Scientific. We were delighted the medical device community was interested as evidenced by both venues being filled to capacity! Our sincere thanks to those who attended.
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News

R&Q adds former TÜV Rheinland North America Lead Auditor of Medical to team

Regulatory & Quality Solutions (R&Q) continues to grow aggressively – all while never sacrificing the high quality of service our clients have come to expect (this is a guiding principle and will never change) – and our latest addition to the team is particularly exciting. R&Q is thrilled to formally announce Ron Sills as Senior Principal Specialist and subject matter expert for CERs and the EU MDR. He's been with us since February and has already made significant contributions to the medical device community while at R&Q. In March, Ron supported R&Q's webinar on sufficient clinical evidence (now available on demand) and acted as a panelist for both of R&Q's highly-rated Advanced EU MDR and CER Workshops in Minneapolis and Boston. In his role at R&Q, Ron will provide technical leadership and support to R&Q's clients in all areas concerning EU compliance and remediation. His addition to the team enhances and expands R&Q's capabilities and positions the company to make an even greater impact on our medical device clients... and the industry as a whole.
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Webinars

EU MDR for Combination Products

More companies will require notified body involvement.
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Webinars

Biocompatibility

EU MDR and the changing regulatory landscape.
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Events

Advanced EU MDR and CER Workshop – Minnesota

March 14, 2019 — Minneapolis, MN
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Events

Advanced EU MDR and CER Workshop – Boston

March 19, 2019 — Newton, MA
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Webinars

Sufficient Clinical Evidence

A notified body perspective.
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Webinars

Top 10 EU MDR and CER Questions

Answers to the most popular questions we receive.
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Webinars

Economic Operators

Are they ready for EU MDR? Are you?
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Webinars

Understanding EU MDR and the Roadmap to Compliance

A guide to EU MDR for small companies.
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Webinars

CERs - Tips, Tricks, and Lessons Learned

Clinical background on the new requirements.
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Webinars

Proactive Post-Market Surveillance

The requirements and staff it takes.
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Webinars

EU MDR / CER Portfolio Planning

Know the essential EU MDR portfolio planning requirements.
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Webinars

Preparing your CER for MDR

Gathering clinical evidence.
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Webinars

QMS for EU MDR

Does your quality system meet the additional requirements?
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Webinars

Risk Management Updates

What to do with your process to meet the EU MDR/IVDR requirements.
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Events

Medical Alley Association Annual Dinner

April 24 — Minneapolis, MN
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Events

RAPS Convergence

September 21-24 — Philadelphia, PA
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Events

The MedTech Conference (AdvaMed)

September 23-25 — Boston, MA
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EU MDR | CERs

🏅 Top 10 Questions: EU MDR and CER [Upcoming Webinar]

Are you registered for our next free webinar yet? It's one you won't want to miss and it's next week!
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EU MDR | CERs | California | DeviceTalks West

Our Advanced EU MDR and CER Workshop is coming to California in December at DeviceTalks West

  Note: Presenters/Panelists listed below subject to change. R&Q is bringing our Advanced EU MDR and CER Workshop to DeviceTalks West! Join us Dec.12 for an extensive, detailed look at EU MDR and CERs through the lens of top industry experts who have successfully implemented large-scale EU MDR programs and completed 100’s of CERs. These experts have seen what works and what doesn't, and will be sharing tips, tricks, and lessons learned. What's more, if you'd only like to attend the workshop and not the entire conference, we've made that possible. Here are the registration codes: RQFULL - 50% full conference pass RQWORKSHOP - $75 for workshop only (also includes networking opportunities) At a small company and think this doesn't apply yet? This may not be on your radar, but it should be. You'll learn from the successes and failures of larger companies who are several months into the transition, and acquire the knowledge to nimbly navigate the transition efficiently. If your organization has many device changes planned, it’s crucial to get started in order to complete the transition by May 2020. Read on for a closer look at the workshop and an exclusive registration discount code for DeviceTalks Boston.
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New webinars, major events... hello, fall!

First thing's first: our free webinars are back. Over the next three months – beginning September 25 – we'll be covering combination products, EU MDR, and economic operators. Slides, recordings, and Q&A will be made available to everyone who registers. We've made it easy for you to sign up once and get on the list for all three webinars below. Why sign up? Because our industry-leading experts are sharing lessons learned from experiences they've lived through. We present the most important information and compile critical takeaways we believe you can implement right away.    
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EU MDR | CERs | DeviceTalks Boston

Not your average EU MDR and CER workshop

Note: Presenters/Panelists listed below subject to change. DeviceTalks Boston is Oct. 8-10 this year and as part of it, R&Q is helping to organize an Advanced EU MDR and CER Workshop. It's an extensive, detailed look at EU MDR and CERs through the lens of top industry experts who have successfully implemented large-scale EU MDR programs and completed 100’s of CERs. They've seen what works... and what doesn't, and will be sharing tips, tricks, and lessons learned. At a small company and think this doesn't apply yet? This may not be on your radar, but it should be. You'll learn from the successes and failures of larger companies who are several months into the transition, and acquire the knowledge to nimbly navigate the transition efficiently. If your organization has many device changes planned, it’s crucial to get started in order to complete the transition by May 2020. Read on for a closer look at the workshop and an exclusive registration discount code for DeviceTalks Boston.
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Minnesota | DeviceTalks | DeviceTalks Minnesota

Taking it up a notch at DeviceTalks Minnesota

DeviceTalks Minnesota is right around the corner and we couldn't possibly be more excited - really. June 4-5 is only a little over three weeks away! We've witnessed the growth of this event first-hand over the past few years and this year we're confident will be the best yet, especially considering the new partnership with the Medical Alley Association (MAA). R&Q sees this as the premier medtech event in Minnesota in 2018, which is why we've decided to be a Platinum Sponsor this year. Beyond that and most importantly, we're helping to craft the educational content of the Regulatory 2.0 track, presented by MAA. 
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regulatory | EU MDR | CERs

🔑 Unlock the Secrets to CERs in our May Webinar

Unlock the secrets to complying with the increased requirements for CERs in May's free R&Q webinar:   CERs – Tips, Tricks, and Lessons Learned     The session will be on Tuesday, May 22 from 1:00pm - 2:00pm EST. The presentation slides, webinar recording, and Q&A will be made available to registrants - whether you can attend the live presentation or not.   Webinar details You have heard about the increased requirements for clinical evaluation with MEDDEV 2.7/1 Rev 4 and the MDR. You may be working on new templates and updating your CERs.   And now come the questions... What do these requirements really mean? Why are we doing this? How are we going to get this all done?  
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EU MDR | Technical Documentation

💼 EU MDR – Proactive Post-Market Surveillance [Upcoming Webinar]

It's time for our next free R&Q Intelligence Series webinar. The session – EU MDR – Proactive Post-Market Surveillance: The requirements and staff it will take to do it. – will be held Tuesday, April 24ᵗʰ from 1:00pm - 2:00pm EST. If you can't view the webinar live, we encourage you to register anyway, as the presentation slides, webinar recording, and Q&A will be shared with all registrants. Click below to sign up and read on for more details about the webinar. We hope you can join us!  
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Webinar Q&A: Preparing your CER for MDR

Note: R&Q's first Intelligence Series webinar of 2018 will be held on January 23rd – QMS for EU MDR: Does your quality system meet the additional requirements? Sign up here! -- Back in November and as part of the R&Q Intelligence Series, we held the webinar, Preparing your CER for MDR: Gathering Clinical Evidence. The upcoming EU MDR requires enhanced clinical evidence to support the device whether you have Class I or Class III products. For products that have been on the market a long time there may be limited or no clinical studies, and yet, the new European Medical Device Regulations require your organization to provide clinical evidence on all your devices. The time to plan and act on these changes is most certainly now. At the conclusion of the November webinar we answered many questions (the most of any webinar - so thank you!), and some of those questions and answers are below. To read more about the webinar, read all questions and answers, and gain access to the slides and recording, check out the on-demand webinar.
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Medical Devices | News | R&Q | EU MDR | R&Q Hires

Welcome, Jacob Foster: Regulatory and Quality Solutions' New Senior Principal Engineer

Jacob Foster brings 20+ years of medical device and pharmaceutical regulatory, quality, and project management experience to R&Q. He also brings an engaging personality, eager to do more for clients. Pittsburgh, PA -- Regulatory and Quality Solutions LLC (R&Q) exists to improve people’s lives and bring more safe and effective medical devices to market for medical device and combination product companies. Our results derive from a cohesive, hard-working, entrepreneurial, and supportive culture – a culture in which Jacob Foster effortlessly fits in. R&Q is truly ecstatic to announce that Jacob Foster has been named Senior Principal Engineer. An industry veteran of the global pharmaceutical and medical device industries, Foster brings extensive management, project leadership, and hands-on quality systems development experience to R&Q’s rapidly expanding operations team. His years of experience in the ever-changing regulatory environment  - including the upcoming and all-important EU MDR - strengthens R&Q's ability to expertly and efficiently serve clients. Foster has lived through uncertain times in the industry and despite the complexity of changes, has a track record of successfully navigating and deciphering them. “I met the team at R&Q about three years ago, and became “fast friends” with each and every team member I was introduced to," said Foster. "So when the opportunity arose to join R&Q, it was one of the easiest decisions I have ever had to make. The culture of R&Q and the earnest sincerity to contribute to patient safety and client success is tangible. Who would not want to be a part of that?”
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CER | Clinical Evaluation Report | EU MDR | Clinical Evidence

Preparing your CER for MDR [Upcoming Webinar]

The upcoming EU MDR requires enhanced clinical evidence to support the device whether you have Class I or Class III products. For products that have been on the market for a long time there may be limited or no clinical studies, and yet, the new European Medical Device Regulations require your organization to provide clinical evidence on all your devices. R&Q's next Intelligence Series webinar, Preparing your CER for MDR: Gathering Clinical Evidence, will be held on Tuesday, Novemer 28th from 1:00pm - 2:00pm EST.  The presentation slides, webinar recording, and Q&A will be made available to registrants. Register in seconds at the link below, and read on for full webinar details. We hope you'll join us!
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QMS | News | iso 13485 | AAMI | Resources

ISO 13485:2016 Companion Handbook Now Available

ISO has published a companion handbook to ISO 13485:2016, Medical devices-Quality management systems - Requirements for regulatory purposes. From AAMI: It provides users with practical guidance and accurate interpretation of the requirements specified in the standard. It offers device manufacturers step-by-step guidance applicable to the all stages of a medical device's life cycle from gathering customer requirements to design and through to post-market surveillance of devices. This go-to resource is ideal for regulatory, compliance, quality management professionals who are committed to implementing and maintaining a quality management system that is effective and meets applicable regulatory requirements.
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Webinar Q&A: EU MDR / CER Portfolio Planning

In September and as part of the R&Q Intelligence Series, we conducted the webinar, EU MDR / CER Portfolio Planning: Know the essential EU MDR portfolio planning requirements. Portfolio planning is a key aspect of interfacing with your notified body. The upcoming EU MDR changes are significant, potentially impacting your device classification and the need for clinical data. Considering the overall timeline – including ISO 13485:2016 (March 2019) and MDSAP (if selling in Canada; Jan. 2019) – it will be difficult to get on notified bodies’ schedules. At the conclusion of the webinar we answered several questions, and a sampling of those questions and answers is below. To read more about the webinar, read all questions and answers from the session, and gain access to the slides and recording, check out the on-demand webinar.
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Webinar Q&A: Risk-Based Approach to ISO 13485:2016

Last month and as part of the R&Q Intelligence Series we conducted the webinar, Risk-Based Approach to ISO 13485:2016: Risk considerations and implementation. Risk considerations and implementation of a risk-based approach in your QMS processes is one of the most significant changes to the current version of ISO 13485. Medical device organizations must define how they manage risk in their processes and how the risk of one process affects other risk aspects of the QMS. At the end of the webinar we answered several questions, and a sampling of those questions and answers is below. To read more about the webinar, read all questions and answers from the session, and gain access to the slides and recording, check out the on-demand webinar.
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CER | EU MDR

EU MDR / CER Portfolio Planning: The Essential Requirements [Free Webinar]

What?  Please join us for September's free R&Q Intelligence Series webinar: EU MDR / CER Portfolio Planning: Know the essential EU MDR portfolio planning requirements. The session will take place Tuesday, September 26 from 1:00pm - 2:00pm EST.   Portfolio planning is a key aspect of interfacing with your notified body. The upcoming EU MDR changes are significant, potentially impacting your device classification and the need for clinical data. Considering the overall timeline – including ISO 13485:2016 (March 2019) and MDSAP (if selling in Canada; Jan. 2019) – it will be difficult to get on notified bodies’ schedules. The time to plan is now.
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MEDDEV 2.7/1 & CERs: Questions and Answers

Clinical evaluation requirements have been changing, with the latest impact coming from MEDDEV 2.7/1 Rev 4. Preparing for and meeting these requirements is important because the grace period offered by some notified bodies is ending and clinical evaluation reports (CERs) are being audited for compliance with the latest MEDDEV revision. Furthermore and once the regulation comes into force, the European Medical Devices Regulation (MDR) will impact CERs as well. It is important to be proactive to ensure CERs will meet your notified body expectations. You must review your clinical strategy carefully. R&Q recently presented the webinar, MEDDEV 2.7/1 & CERs: Know the changes and what to do. Towards the end of the session we answered several questions, a sample of which are below. To see all questions and answers from the session - along with the slides and recording - check out the on-demand webinar.
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remediation | FDA | Case Studies | Clinical Evaluation Report | MEDEV 2.7/1

Clarifying the Clinical Evaluation Requirements: A Case Study

About R&Q's Case Studies: We hope this Clinical Evaluation Report case study is valuable to you. Here are our currently available case studies. Subscribing to our blog is the best way to know when future case studies and other resources are available. Questions on this particular subject? Contact us. Challenge Design changes and MEDDEV 2.7/1 rev 4 compliance. The client was implementing multiple design changes on a Class III implantable heart transplant device that required a submission to the Notified Body. As part of this submission, the Clinical Evaluation format needed to be updated to provide clarity and comply with MEDDEV 2.7/1 rev 4. The Notified Body provided feedback on the prior clinical evaluation reports and the client needed assistance in interpreting and addressing the feedback. The primary roadblocks / challenges were interpreting the information provided by the client, identifying and requesting any missing or insufficient documentation, and ensuring the information was comprehensive and understandable to the Notified Body once included in the Clinical Evaluation Report.
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Regulatory Affairs | EU MDR

EU MDR: Your Questions, Our Answers

On May 5, 2017 the EU MDR (Medical Device Regulation) was published in the EU Official Journal. This date starts the three-year mandatory transition period where the MDR will replace the MDD (Medical Device Directive). The expanded scope of the MDR combined with the time frames for compliance is compelling medical device companies to focus significant attention on transition strategies and will require substantial hands-on work. R&Q recently presented the webinar, EU MDR: Assessing the Impact and Next Steps. During the session we answered several of your questions, a sample of which are below. To see all of the questions and answers from the session, along with the slides and recording, check out the on-demand webinar.
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R&Q

Regulatory and Quality Solutions Names Julie Maes Director of Territory Operations – Northern Lakes Region

Maes brings 25+ years of medical device regulatory, quality, and project management experience to R&Q. Pittsburgh, PA -- Regulatory and Quality Solutions LLC (R&Q), a provider of industry-leading regulatory and quality engineering services to medical device and combination product companies, announced that Julie Maes has been named Director of Territory Operations for Minnesota. An industry veteran of the global healthcare and medical device industry, Maes brings extensive management and hands-on quality systems development experience to R&Q’s expanding Minnesota area operations. In her role at R&Q, Maes will manage designated resources to guarantee the highest quality consulting and complete customer satisfaction in the region. She will also contribute to R&Q’s Center of Excellence as a subject matter expert, providing industry education on the most critical and timely regulatory and quality challenges facing our market.
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cybersecurity | Regulatory Intel | webinar | Quality Intel

[Free R&Q Webinar] Cybersecurity for Medical Devices: The regulatory and quality ramifications.

What?  Please join us for a free R&Q Intelligence Series webinar: Cybersecurity for Medical Devices: The regulatory and quality ramifications. The session will be held on Tuesday, July 25 from 1:00pm - 2:00pm EST.
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webinar | CER | MEDDEV

MEDDEV 2.7/1 & CERs: Know the Changes and What to Do [Webinar]

Part of your month, [almost*] every month: R&Q Intelligence Series webinars are held on the fourth Tuesday of every month. These free webinars from some of the medical device industry's leading-most experts are designed for reporting on and analyzing the top industry trends and topics in the medical device space, each providing key and actionable takeaways for attendees. Slides and recordings will be made available to all registrants. Next up: July 25th, where we'll discuss cybersecurity (*there will be no R&Q Intelligence Series webinar in June).
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webinar | EU | Europe | European Union | EU MDR

EU MDR: Assessing the Impact and Next Steps [Webinar]

Part of your month, every month: R&Q Intelligence Series webinars are held on the fourth Tuesday of every month. These free webinars from some of the medical device industry's leading-most experts are designed for reporting on and analyzing the top industry trends and topics in the medical device space, each providing key and actionable takeaways for attendees. Slides and recordings will be made available to all registrants. Next up: May 23rd, where discuss MEDDEV 2.7.1 & CERs.
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webinar | audits | FDA | MDSAP

MDSAP: What is it? Is it for me? How will I get it done? [Webinar]

Part of your month, every month: R&Q Intelligence Series webinars are held on the fourth Tuesday of every month. These free webinars from some of the medical device industry's leading-most experts are designed for reporting on and analyzing the top industry trends and topics in the medical device space, each providing key and actionable takeaways for attendees. Slides and recordings will be made available to all registrants. Next up: April 25th, where we'll discuss EU MDR.
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QMS | webinar | Risk | iso 13485

A Risk-Based Approach to Your QMS Implementation - ISO 13485:2016 and ISO 9001:2015 [Webinar]

Part of your month, every month: R&Q Intelligence Series webinars are held on the fourth Tuesday of every month. These free webinars from some of the medical device industry's leading-most experts are designed for reporting on and analyzing the top industry trends and topics in the medical device space, each providing key and actionable takeaways for attendees. Slides and recordings will be made available to all registrants. Next up: March 28th, where we'll discuss the Medical Device Single Audit Program (MDSAP).
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remediation | FDA | 510(k) review | 510(k) | Case Studies | Acquisitions

Acquisition Regulatory Assessments: A Case Study

About R&Q's Case Studies: We hope this Acquisition Regulatory Assessments case study is valuable to you. Here are our currently available case studies. Subscribing to our blog is the best way to know when future case studies and other resources are available. Questions on this particular subject? Contact us. Challenge Investigating acquired products and associated FDA clearances. A client took ownership of numerous products they had obtained through an acquisition. Remediation of the regulatory documents was needed, which included a review and evaluation of the 510(k) products to establish whether or not the current marketed products aligned with the existing FDA clearances. R&Q conducted a 510(k) inventory, which required a significant amount of investigation work to compile a list of all applicable products and associated 510(k) clearances, as well as non-filing justification (NFJ) with regard to design changes.
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R&Q | Engineered By Women

Regulatory and Quality Solutions (R&Q) Certified By the Women’s Business Enterprise National Council

R&Q, provider of industry-leading regulatory and quality consulting and engineering services to medical device companies, is proud to announce national certification as a Women’s Business Enterprise by the Women's Business Enterprise Council-PA-DE-sNJ, a regional certifying partner of the Women’s Business Enterprise National Council (WBENC). The designation signals a competitive advantage for R&Q’s FDA-experienced team of more than 80 RA/QA experts as medical device and pharmaceutical companies often look to vary their supplier base with more diversity and/or minority-owned businesses. The honor is especially meaningful to Cofounder and President, Maria Fagan, and has been a long time in the making...
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Pittsburgh | R&Q | Philadelphia

Headway in PA: Announcing Dedicated Operations Directors in Pittsburgh and Philadelphia

In 2016 R&Q expanded its activities and the amount of clients served in the northeast (specifically, the greater Boston region), formally launched R&Q in Minnesota, and continued to service new and existing clients throughout the state of Ohio. In 2017 we plan to strengthen our capabilities in those areas and others by hiring some of the most qualified regulatory and quality professionals in the industry (who also are a cultural fit for R&Q). But with that said, we'll never, ever lose sight of where we started and ultimately call home: Pennsylvania. R&Q has hired - or rather, promoted from within - dedicated operations directors in Pittsburgh and Philadelphia. Each director is tasked with ensuring R&Q is represented in the territory through: Serving medical device clients and helping them thrive Engaging in regional marketing/networking initiatives Ensuring the growth of ongoing sales Read on to learn more about R&Q's Jon Gimbel and Matt Burger.
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Case Studies | process validation

Process Validation Case Study: Know What You Know... and What You Don't

About R&Q case studies: We hope this process validation case study helps you understand how we serve our medical device clients in this area. If you have specific process validation questions please contact us and we'll be happy to help. Looking to solve a different problem? Here are all of our available case studies. Subscribing to our blog is the best way to know when future case studies are available. Challenge Transfer troubles. A company executed site transfer and design transfer together for a newly developed product without an in-depth understanding of the product and its manufacturing process. The lack of detailed product specifications, in-depth process design, and full process validation left the program team searching for a baseline to deem the product as acceptable once the design and equipment was transferred to its new location. The result? The program experienced setbacks in implementation and found itself handling a larger-than-ideal number of nonconforming lots.
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QMS | iso 13485

Vital To-Do for 2017: Prepare for ISO 13485:2016

“Procrastination is the bad habit of putting of until the day after tomorrow what should have been done the day before yesterday.” - Napolean Hill It's really never too early, especially when it comes to renewing the certifications you need to keep your product on the market. In fact, the time is now to start your transition to ISO 13485:2016. Certification bodies will have difficulty having enough auditors and long wait times are expected. Don’t get caught in that last minute rush to renew certifications. R&Q’s QMS expert, Mark Swanson, was a member of the ISO working group that revised ISO 13485, so R&Q can bring you detailed information on the intent behind the requirements. R&Q on the whole will ensure you can fully prepare for your certification audit with minimal issues, keeping your product on markets worldwide.
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iso 10993 | iuvo BioScience

Slides and Webinar Recording: Chemical Characterization Requirements

Missed our webinar with iuvo BioScience - Chemical Characterization Requirements: ISO 10993-18 and Extractables & Leachables Requirements? Good news: you can now download the slides and view the recording.
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Ohio | BioOhio | Regulatory 101 | startups

Next Up: FDA Regulatory 101 with Combination Products Spotlight at Heal Ohio Conference

This is the last FDA Regulatory 101 installment of the year for our partnership with BioOhio. After events in Cincinnati and Columbus, the October 27th event will be held during the 2016 Heal Ohio Conference at the University of Akron. Former FDA Consumer Safety Officer Jake O'Donnell (25+ years of FDA experience) will be presenting and answering questions, in addition to other industry experts. What's more, those who register for the 101 event are eligible for a discount to the conference. Keep reading to see the agenda and register to attend.
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massmedic | CAPA

CAPA on CAPA: Webinar Slides and Recording

Missed our CAPA on CAPA webinar with MassMEDIC? Now you can download the slides and view the recording.
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iuvo BioScience | ISO 10993-18

Free Webinar: Chemical Characterization Requirements: ISO 10993-18 and Extractables & Leachables Requirements

What? This joint webinar presented by Regulatory and Quality Solutions (R&Q) and iuvo BioScience is focused on the requirements for chemical characterization in the healthcare industry. Specifically, it will discuss the standards required for ISO 10993-18 chemical characterization for medical devices and compare the ISO requirements with the pharmaceutical industry requirements and best practices for extractables and leachables testing. The goals for this webinar are to explain the standards for both industries, discuss the testing methodologies required, and provide some case study experience from an E&L perspective. You can register here.
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Medical Devices | quality systems | News | iso 13485 | R&Q | Minnesota

Minnesota Momentum: R&Q Hires Member of ISO Technical Committee 210, Mark Swanson

Mark Swanson is R&Q's new Director of Minneapolis–Saint Paul (MSP) Territory. Welcome, Mark! Mark's addition firmly establishes R&Q in the Twin Cities and prepares R&Q to handle growth in the region. The hiring also builds upon R&Q's existing technical leadership, increasing company-wide capability. Mark will certainly be seen and heard across Minnesota on behalf of R&Q, starting today at MD&M Minneapolis! Mark is a Senior Member of ASQ and holds ASQ certifications as a Certified Biomedical Auditor (CBA), Certified Quality Engineer (CQE) and Certified Manager of Quality/Organizational Excellence (CMQ/OE). Read on as we ask Mark three questions about his work on the ISO Technical Committee and shed light on his background/experience.
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warning letter | remediation | FDA | supplier quality | Case Studies

Revamping Supplier Quality: A Case Study

About R&Q's Case Studies: We hope this Supplier Quality Remediation case study is valuable to you. Here are our currently available case studies. Subscribing to our blog is the best way to know when future case studies are available. Questions on supplier quality remediation? Contact us. Challenge The FDA found that not following your procedure is a problem. A multibillion dollar client had a supplier quality process that was not being executed, and was not aligned to regulations (21 CFR 820.50). Suppliers were not being audited at the prescribed regularity, some suppliers rated as low risk were making high risk parts, and others supplied product that did not meet current specifications. The results of an FDA inspection resulted in a Warning Letter that ultimately required third party audit certification. The organization had to react by proposing a plan to halt distribution of two product lines in order to focus on a permanent and comprehensive systemic solution.
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remediation | FDA | Case Studies | CAPA | CAPA remediation

When CAPA Needs a Corrective Action: A CAPA Remediation Case Study

About R&Q's Case Studies: We hope this case study is valuable to you. Here are our currently available case studies. Subscribing to our blog is the best way to know when future case studies are available. Questions? Contact us. Challenge The FDA found problems you didn't think were there. A multibillion dollar client has been marketing product for years with insufficient attention to corrective actions. An analysis of the CAPA records showed 62 open CAPA’s at inception, with an average age of 1.3 years each. The client believed that their process was adequate and therefore did not apply the necessary resources to find a solution. Additional lack of response to FDA Warning Letters resulted in a consent decree, which included the need to improve the CAPA process.
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Regulatory 101 | PA Bio | Philadelphia | startups

Med Device and Med Tech Startups: Master Regulatory Basics and More! September 22 in Philly

We all gotta start somewhere... and Pennsylvania Bio and Quorum have helped us put together an invaluable event to help your early-stage medical device company hit the ground running. Seasoned experts, such as R&Q's President Maria Fagan and Buchanan Ingersoll & Rooney's Will Garvin will be presenting content and answering any and all of your questions and curiosities (you have the chance to submit them in advance during registration). The Regulatory 101 for Medical Device And Med Tech session is September 22 in Philadelphia and we encourage you to register early!
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Quality System | regulatory | massmedic

Free Webinar: CAPA on CAPA, Presented by MassMEDIC and R&Q - Register Now!

CAPA is often overlooked as an integral component of a quality system. More often than not, the FDA can trace deficiencies in a system directly back to the CAPA system. However, an effective quality system needs more than just a rework of the outcome of the ineffective CAPA system. It needs a rework of the system itself. 
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start ups | medical device | startups

R&Q's Christine Santagate Featured in Medical Design & Outsourcing

Staying at the forefront of the medical device industry takes work - a lot of it, in fact. Communication with R&Q's peers in the industry is in large part how our employees do it, and a big part of that is addressing hot topics in the industry. R&Q's own Client Solutions Advisor Christine Santagate was featured in MassDevice's May 2016 issue of Medical Design and Outsourcing in an article titled, "Everything You Ever Wanted to Know about Starting a Medical Device Company." The publication serves as a fantastic how-to guide for startup companies. Here's what she had to say.
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FDA | Ohio | BioOhio | Regulatory 101 | Regulatory 201

July is a BIG month for R&Q in Columbus, OH

■ ■ ■ Are you an Ohio Bioscience Expo & Showcase attendee here to register for the FDA Regulatory 101 Series? ■ ■ ■   The Ohio Bioscience Expo & Showcase and next FDA Regulatory 101 Series event are on July 27th and 28th, respectively. If you're outside of Columbus but in Ohio, you're likely close, and there's no better time for a road trip than the middle of summer! In fact, here are drive times to Columbus, OH from some nearby cities: Cleveland: 2 hours 9 mins Cincinnati: 1 hr 41 mins Toledo: 2 hr 29 mins Akron: 1 hour 55 mins Dayton: 1 hour 5 mins Canton: 2 hours 2 mins If you can drive to Columbus, OH in a single day, the only thing between you and R&Q on July 27th and 28th is a little open road. Below are all the details you need to know and be sure to save your seat for the FDA Regulatory 101 Series event!
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iso 13485

10 Tips for Adopting the Updated ISO 13485:2016 Standards: Webinar Slides and Recording

Missed our latest webinar on this year's ISO 13485 changes? Now you can download the slides and recording. R&Q's Director of Regulatory Affairs Nancy Morrison and Client Solutions Advisor Christine Santagate walked through 10 tips for adopting the latest changes. From conducting a gap assessment and creating a quality plan to modifying procedures/processes and auditing, they communicated industry best practices to help those in the industry confidently take the next steps in their process.
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usability | FDA | human factors | pma supplement | PMA | Case Studies | IEC 62366

FDA Approved: A Human Factors and Usability Case Study

About R&Q's Case Studies: We hope you enjoy our latest case study. View all of our available Case Studies. Subscribing to our blog is the best way to know when future case studies are available. FDA Approved: Creating and Implementing a Compliant Usability Engineering Process Challenge PMA supplement for usability updates not approved. A medical device manufacturer made an update to the design of their Class III device to improve usability and promote proper care and maintenance, and they submitted a PMA supplement to the FDA for the changes. The PMA supplement included a human factors test report from a usability study intended to demonstrate the effectiveness of the changes. The company received a letter from the FDA expressing concern with the level of evidence provided by their human factors testing. The FDA noted that the recent usability study had focused on ease of handling rather than comprehensive safe and effective use, engaged company employees as study participants rather than unaffiliated representative users, and failed to demonstrate that risks related to the most critical aspects of device use had been appropriately addressed in the design and evaluated in testing. The FDA requested that the client conduct another human factors study that addressed these concerns, validating safe and effective use of the device by intended users.
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Medical Devices | UDI | MD&M East | md&m | Conferences

4 Things R&Q Learned At MD&M East

What an action-packed three days MD&M East was this year! Our team is exhausted, but in the absolute best way possible. I'm not sure how anyone who attended the show could've escaped the exhaustion... as the exhibit floor was BIG. If you're reading this and attended, hopefullly you found the conference worthwhile. We certainly did. Here are four things we learned this year.
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Engineered By Women | entrepreneurship

R&Q: Engineered by Women

Did you know that women are half as likely as men to start businesses? That's a statistic R&Q wants to help change. Aside from the importance of gender and fairness issues, women entrepreneurship fuels economic growth. R&Q is Engineered by Women. We're proud to have been started and now led by our female co-founders and owners, Maria Fagan and Lisa Casavant. What they've accomplished and continue to accomplish over the course of their careers prove they are driven, visionary, and immensely influential in the medical device industry. They most certainly have been positively influential to R&Q's medical device clients. Since the LLC was formed in July of 2008, Maria and Lisa's mission has centered on customer and employee satisfaction. This has helped us grow to more than 70 QA/RA professionals - including former FDA staff and 25+ year industry veterans - and establish a corporate culture in the device industry that we think is second to none.
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UDI | massmedic

A Whole New World of UDI: Slides and Recording

If you have any UDI needs or questions, do not miss this post.
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FDA | PA Bio | Philadelphia | Pennsylvania

Presentation and Networking at PA Bio: Practical Considerations for Avoiding FDA Compliance Problems (BEING RESCHEDULED)

NOTE: This event has been cancelled and is being rescheduled. Organizer Regulatory and Quality Solutions (R&Q) What? A presentation and networking event over lunch at PA Bio: Practical Considerations for Avoiding FDA Compliance Problems, and How to Manage Them If They Arise   In the session you will learn from a former FDA consumer safety officer of 20 years what it takes to proactively improve your systems to avoid problems, and proficiently manage issues if they happen to occur. First-hand experiences of how R&Q helped remediate projects will be shared, and best practice strategic and tactical solutions will be given for how to avoid those situations in the first place. We’ll also investigate emerging oversight trends, common problems, classic times in business cycle when compliance issues arise, and other specific challenges.
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iso 13485

The New ISO 13485 Standards are Here! Sign Up for a Free R&Q Webinar

The world's most well known standards for medical device quality management have been updated for the first time since 2003. Released in March by the International Organization for Standardization, ISO 13485 provides the universal requirements for manufacturers and service providers to comply to regulatory requirements. The standards aim to establish consistent processes for medical device design, progression, installation and distribution, focusing on the safety of the total life span of the device. Some of the essential changes: Globally aligning regulatory requirements Applying risk management practices throughout the quality managment system Attention to supplier sourcing and selection Supplemental requirements for design activities, such as validation and verfication More specific requirements for Design and Development, Corrective Action and other applications Required Medical Device File to validate compliance to new standards  The standards must be adopted by 2019, which could prove to be a difficult task for manufacturers. Commencing adoption sooner rather than later will aid a steady transition, and that's why we're hosting a free webinar.
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FDA | compliance | UDI | massmedic

MassMEDIC Webinar: A Whole New World of UDI - May 18

If you missed R&Q's Paul Robinson discuss UDI during R&Q's afternoon workshop at BIOMEDevice in April, here's a second chance. A similar presentation and discussion will be offered in conjunction with MassMEDIC on Wednesday, May 18th at 11:30am EST. All the details - including the link to register - are below!
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FDA | compliance | advamed

AdvaMed Webinar: Avoiding and Managing FDA Compliance Problems - Monday, May 9th

Did you miss former FDAer Jake O'Donnell speak about avoiding and managing FDA compliance problems during R&Q's afternoon workshop at BIOMEDevice earlier this week? If so, we have news especially for you: he will be presenting on a similar topic via a webinar on Monday, May 9th at 1:00pm EST. The webinar is presented through AdvaMed, and all the details - including a link to register - are below.
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inspection | fda inspection | FDA | white paper | compliance

NEW White Paper - Practical Considerations for Avoiding Regulatory Escalation: R&Q's Latest, In-Depth White Paper from a Former FDA Consumer Safety Officer

There’s a formula for effectively managing an adverse FDA inspection and the newest R&Q white paper shares it. Learn all the practical considerations for avoiding regulatory escalation from a former FDA Consumer Safety Officer: R&Q's Jake O'Donnell. This is your free, ultimate compliance resource, that you can download now: Managing An Adverse FDA Inspection: Practical Considerations for Avoiding Regulatory Escalation. Preview the first four pages of the 24-page white paper below (click to enlarge), and download it in its entirety at the link! We hope you find the white paper valuable. If you do, be sure to share it with your colleagues and industry peers. Subscribe to R&Q's Blog to stay updated on when new white papers and other content is available.
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Minnesota | Medical Alley

Minnesota, Here We Come: See You at the 2016 Medical Alley Annual Meeting, April 27th

R&Q will be a Supporting Sponsor at the Medical Alley Association's 2016 Annual Meeting, April 27th. If you're not familiar, the association is a state-based member organization servicing the health technology community who works to promote Minnesota's Medical Alley by influencing policy at the state and federal levels. R&Q's Lisa Casavant (Cofounder/VP) and Juli Denny (VP Sales and Marketing) will be onhand so keep a look out for them and our exhibit table at the event. If you'd like to schedule specific time with us before or after the event, contact us to let us know.
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IVD | compliance | UDI | Boston | IVDR | BIOMEDevice | Workshops

R&Q's Can't-Miss Education Event of the Year: An Afternoon Training Workshop at BIOMEDevice in Boston, April 13th

Those in the northeast, get ready! Not only will R&Q be exhibiting at this year's BIOMEDevice show (booth 640) and sponsoring MassMEDIC's Annual Conference, but we'll be presenting an afternoon training workshop (three separate sessions) free to attendees of the BIOMEDevice show on Wednesday, April 13th from 1:00 - 4:00pm. The event will cover compliance, IVDR, and UDI... and you can choose to attend whichever session(s) you like. This will be one of R&Q's premier education events of the year and we're incredibly excited about the team we'll have on hand to share their expertise and experience, moderate discussion, and field questions. Keep on reading for complete details.
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Clinical Studies | Case Studies | Clinical Evaluation Report

When Benefit Outweighs Risk: Creating a Successful Clinical Evaluation Report - A Case Study

About R&Q's Case Studies: We hope you enjoy our third case study. View all of our available Case Studies. Subscribing to our blog is the best way to know when future case studies are available.   Challenge High volume of data... and differing opinions. A client's product is utilized on critically ill patients in intensive care units. As a result, comorbidities and adverse events during the use of the device are inevitable. There were more than a thousand customer complaints and hundreds of serious adverse events reported to public databases for the subject device and comparative devices. Notified body findings on the previous clinical evaluation reports and internal conflict over the requirements added to the confusion.
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regulatory strategy | Case Studies

5 Heads are Better Than 1: De-Risking Your Regulatory Pathway Using a Team Approach - A Case Study

About R&Q's Case Studies: We hope you find value in our second case study. View all of our available Case Studies. Subscribing to our blog is the best way to know when future case studies are available.   Challenge Regulation doesn't have to be a barrier to innovation. A client was developing a software package using Big Data to provide clinical decision support for physicians. They initially believed a premarket approval (PMA) could be required for the product depending on the claims that would be made. They were also concerned about the potential cost of clinical trials and the overall timing of bringing the product to market.
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remediation | Case Studies | Design History File Remediation

Introducing Our First In A Series of New RQM+ Case Studies: Design History File Remediation

About RQM+ Case Studies: Our goal in producing case studies is to succinctly demonstrate how RQM+ applied our unique expertise to tackle a client's challenge, implement a competent solution, and demonstrate real results. We will post each case study to our blog and offer a downloadable PDF as well, perfect for printing and/or emailing to colleagues and industry peers. Our first case study focuses on Design History File Remediation and we hope you enjoy it. The content of future case studies will be around the services RQM+ offers, including areas of regulatory, quality systems, design assurance, product quality, and post-market surveillance - particularly remediation. Subscribing to our blog is the best way to know when future case studies are available. View all of our available Case Studies.
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FDA | Ohio | BioOhio | Regulatory 101

Announcing the 2016 FDA Regulatory 101 Series

Medical device professionals in Ohio, are you ready? Last year R&Q teamed with BioOhio to present an ongoing series of 101 medical device events throughout the year. Thanks to participation and feedback from ambitious medical device professionals across Ohio - and the support of our gracious hosts - the events were a success. Because of that, we're thrilled to announce we'll be presenting a new and improved program in 2016! One webinar and three in-person events are on tap for this year, with the first - a webinar on medical mobile apps - scheduled for March 3, 2016. Register for the webinar and see the list of upcoming FDA Regulatory 101 events below.
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510(k) submission | 510(k) review | 510(k) | advamed | Workshops | Education

Hear R&Q and Other Industry Experts Discuss 510(k) Submissions at AdvaMed's Workshop In Irvine, CA

Join R&Q's Marilyn Waxberg and Nancy Morrison as they speak along with other industry experts at AdvaMed's 510(k) Submissions Strategy Workshop in Irvine, CA this month. The event is scheduled for two days: February 22-23. Marilyn is R&Q's Senior Principal Advisor and Nancy is Director of Regulatory Affairs. Nancy will be speaking to The Law and Regulations portion of the agenda alongside Pamela Forrest of international law firm King & Spalding. Both Marilyn and Nancy will be leading the Strategy and Planning section on day two.
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Medical Devices | CT Scanner | Creativity | New York

Revisiting a Classic: The Pirate-Themed CT Scanner

Behold medical device ingenuity at its finest. In 2013 the NewYork-Presbyterian Morgan Stanley Children's Hospital purchased a pirate-themed CT scanner, and the result is an incredible way to put children at ease before being scanned. See the rest of the creativity in pictures below.
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M2D2 | UMass | Boston

R&Q Is Sponsoring The M2D2 $100K Challenge and A Summary of Important Dates

The University of Massachusetts Medical Device Development Center (M2D2) has announced the M2D2 $100K Challenge 2016, a nationwide competition that showcases innovative ideas of early-stage medical device, diagnostic, and biotech companies. R&Q is proud to announce that we are one of several sponsors who will award up to a total of $100K in services (we're also a Platinum Sponsor of M2D2 in general). Winning companies can receive use of the facility's lab and office space, along with engineering, legal, regulatory, clinical and business services.
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Combination Products | Boston

Presentation and Networking: Is A Medical Device Hiding In Your Product Portfolio? Join R&Q at MassBio!

Organizer Us! Regulatory and Quality Solutions (R&Q) What? A presentation and networking event over lunch addressing how an accessory or tool, in reality, is often a medical device.   This session will discuss combination products and the use of accessories with drugs and biologics. We will review examples of product types that may not be obvious and also what to watch out for during the development process. Finally we'll look at some MDR examples where the device types were not initially disclosed or identified correctly.
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Medical Devices | News | FDA | R&Q

Announcing R&Q's Newest Senior FDA Compliance Principal: Former FDA Consumer Safety Officer Jake O'Donnell

R&Q is thrilled to announce the newest member of our team. Jake O'Donnell will act as Senior FDA Compliance Principal beginning February 2016. Jake formerly acted as Consumer Safety Officer (CSO) at the FDA for 20 years.
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Medical Devices | R&Q | Video

We Made a Video About R&Q! Here's Why.

One of R&Q's priorities in 2015 was to find new, distinctive ways to tell our story. We wanted to make it abundantly clear to potential clients and employees that R&Q is first and foremost about improving lives. We also wanted to clearly explain how we improve lives. The result of our brainstorming was to create a short video that takes the viewer through the journey of how R&Q helps our clients - from start to finish.
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News

Welcome To R&Q's New Website!

Welcome to R&Q's updated website! To state it plainly, we've revamped our website to better serve the needs of regulatory and quality professionals in the medical device industry. We hope you find it easy to use. Some changes include more clearly outlined services, additional detail on the white papers we offer, and a video that tells the story about how we help our clients, as seen below. You'll notice that the video is the first call-to-action on our homepage, just under, "We help get medical devices to market faster. And keep them there."
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510(k)

510(k)-Exempt Devices

In the FDA-regulated medical device world, there are 3 classifications for medical devices: Class I, Class II and Class III. The FDA (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/default.htm) provides a rather in-depth overview of how to classify a medical device and the requirements behind each product's classification. What may not be evident, or often discussed in common conversation, is that many Class I and some Class II medical devices are 510(k) exempt.
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