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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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News

Q&A: FDA Emergency Use Authorization (EUA) and EU MDR Article 59

R&Q's May 2020 webinar focused on FDA Emergency Use Authorization (EUA) process and EU MDR Article 59 to release devices needed for prevention and treatment of COVID-19. In this blog post, our knowledgeable FDA and EU MDR regulatory experts sat down to provide answers to your questions from the webinar and we hope that they will shed some light on similar questions that you may have on the topic.
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News

State of the Art (SOTA) Part I: What is a State of the Art Evaluation?

You have been reviewing the 4th revision of the European Commission’s Guidelines on Medical Devices, "MEDDEV 2.7/1 Clinical Evaluation: A Guide for Manufacturers and Notified Bodies Under Directives 93/42/EEC and 90/385/EEC" to make sure you are following all requirements to get (or keep) your medical device on the market in the European Union (EU). The term “state of the art” is mentioned 39 times throughout the document, but what exactly does the European Commission mean by it and what are you supposed to evaluate according to the guidelines? We are glad you asked! In this two-part series, we will start by reviewing what state of the art really means in the EU’s medical device guidelines and what their objective is in using the phrase. What is state of the art? Although state of the art is commonly defined as the newest idea or newest feature, state of the art in relation to European Commission regulations for medical devices does not imply the most technologically advanced solution. First mentioned on page 9 of the MEDDEV 2.7/1 guidance document, state of the art in this context refers to the current state (or current knowledge) of comparable treatment options. Another way to think of it is by asking “what is currently and generally accepted as good practice?” Moreover, the "MDCG 2020-6 Regulation (EU) 2017/745: Clinical evidence needed for medical devices previously CE marked under Directives 93/42/EEC or 90/385/EEC. A guide for manufacturers and notified bodies" gives a definition of state of the art as:
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News

Q&A: RAPS Webcast - PMS Requirements of the EU MDR

R&Q is a Premium Solutions Partner of the Regulatory Affairs Professionals Society (RAPS) and in April, we joined forces to offer up a premium webcast. R&Q Executive Director of Regulatory and Quality Consulting Services, Nancy Morrison, presented PMS Requirements of the EU MDR: Implementation Challenges and Solutions. This webinar is an extended, enhanced, and more up-to-date version of R&Q's own February 2020 webinar. 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. If you were not able to attend this webinar, here's a link where you can sign up to view the on-demand version (and download the slides). R&Q is here to help address any other questions that you may have regarding audits or any other Post-Market Surveillance related topics. Contact us today to find out how we can help! 
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Webinars

Developing an FDA Regulatory Strategy (Part 2)

A definitive guide for entering the US market.
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News

Q&A: Structuring PERs under IVDR

R&Q's April 2020 webinar focused on Structuring Performance Evaluation Reports (PERs) under In Vitro Diagnostic Regulation (IVDR). In this blog post, our knowledgeable IVDR experts sat down to provide answers to your questions from the webinar and we hope that they will shed some light on similar questions that you may have on the topic.     We all know that the clock is ticking down to the IVDR date of application! May 26, 2022 sounds far away, but it's really not considering the size of the step to IVDR compliance for most IVD companies. The transition from MDD to MDR for medical device manufacturers feels relatively small in comparison to the 85% of IVD companies moving from self-certified to notified body audits, complex regulatory systems, and the expectations of much tighter controls over the web of virtual manufacturing and distribution relationships that IVD companies are accustomed to. R&Q is here to help address any other questions that you may have regarding audits or any other IVDR related topics. Contact us today to find out how we can help! Have more questions on IVDR? Join us on Thursday, June 18 for the discussion during DEVICE L❤️VE Live! #10 Transition to IVDR: How far along should we be? Click here to learn more and register for free. If you were not able to attend this webinar, here's a link where you can sign up to view the on-demand version (and download the slides).  
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News

Emergency Use Authorization Stories: The Humn Project

As we collectively watch the world struggle to cope with the devastating impacts of COVID-19, the Emergency Use Authorization Act has given the R&Q team opportunities to provide pro bono regulatory guidance to incredible medical device companies that are prioritizing “giving back” to the communities that desperately need the help. --------- The Humn Project During our recent R&Q DEVICE L❤️VE Live!, our subject matter experts discussed the use of the U.S. Food & Drug Administration’s (FDA) Emergency Use Authorization (EUA) process and E.U.’s Medical Device Regulation (MDR) Article 59 to release medical devices needed for the COVID-19 Public Health Emergency.  Check out the on-demand recording of this show here. The U.S.’s EUA allows medical devices that are uncleared or unapproved by the FDA to be used during a national health emergency, in this instance to help prevent the spread of COVID-19. The EUA process is enabled by a Declaration of a Public Health Emergency by the U.S. Department of Health & Human Services (HHS). This process allows for manufacturers of necessary medical devices, in vitro diagnostic devices (IVD), and pharmaceuticals to request an expedited and interactive EUA review to address unmet needs during a health emergency, as we have seen at the global scale during the current COVID-19 pandemic.  This is where Daniel Clark, President of Linear Health Sciences, an Oklahoma-based medical device company and a longtime client of ours, comes in. Typically specializing in the development of products for various types of medical tubing based on proprietary, breakaway safety-valve technology, Clark partnered with his twin brother and younger sister to found the benefit organization, The Humn Project, to develop a UV-C disinfectant light to combat the spread of the devastating virus with a focus on human safety while using the device. “Thanks to the incredible work R&Q has led, we're in a great position currently looking forward to making a fundamental impact on the war against this invisible enemy.” – Daniel Clark, The Humn Project When R&Q heard that Clark and his team were working to bring an open-source, not-for-profit medical device to help prevent the spread of COVID-19 through the EUA, we knew we had to use our team’s expertise to help their efforts at no expense. To assist the project, our team developed a Regulatory Strategy for the device's EUA submission to support labeling and testing plans by compiling and drafting the pre-EUA submission, serving as Regulatory Correspondent with the FDA, and planning to compile the EUA submission in the near future.   We are proud to support remarkable organizations like Humn Project because it is in R&Q’s blood to want to improve the lives of others and we love to back people making a difference in our communities. As Andrea Clark, Marketing and Commercial Partner of Humn Inc., stated: “Humn Project was built out of this need to strengthen public health by building essential products to benefit society at-large. With no other competing interests, Humn Project recognizes inherent disparities within public health and we are working to even the playing field. Currently, this work includes a novel FAR-UVC disinfectant lamp that reduces the spread of germicidal spores. Working with multiple partners, from engineers and testing experts to the R&Q Regulatory experts, we are expediting our MCM through EUA to get this into clinical essential workers’ facilities as quickly as possible." By providing pro bono regulatory support with the EUA process to obtain FDA authorization for Humn Project, R&Q hopes to support its incredible mission and get the device to market quickly and safely. Brian Clark, Humn’s Managing Partner, reiterates the urgency of getting this technology into the hands of those that need it: "Our mission at Humn is to create open-source technology-driven solutions that positively impact communities with efficient scale. We are a benefit organization, and our first opportunity is to commercialize the promising research on the use of Far-UVC as a germicidal disinfectant. Unlike traditional germicidal UV lamps, research indicates this form of UV light can destroy viruses and bacteria, yet still operate safely around humans. The Far-UVC product that we're bringing to market provides direct support for our communities and front-line workers, and benefit the broader health outcomes of our communities." Want to learn more about this topic? Join us on Tuesday, May 26 for R&Q’s May Webinar on the FDA Emergency Use Authorization (EUA) process and EU MDR Article 59 to release devices needed for the prevention and treatment of COVID-19. In this free webinar, we will discuss both emergency application processes, provide answers to the many questions we have received, and share tips and lessons learned from our experiences. Click the button below to learn more and register: If you are looking for help with EUA or other regulatory needs, check out our Regulatory Services page here and contact us today! Our remarkable remote support team is available across all R&Q services and we're ready to answer any questions or concerns you have about how to stay on track for the EU MDR timeline. We can help you navigate the difficult road ahead and we have ample virtual content to keep you in the know. Source: FDA Emergency Situations Medical Devices. Accessed 11 May 2020. https://www.fda.gov/medical-devices/medical-device-safety/emergency-situations-medical-devices. 
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Events

FDAnews Webinar featuring R&Q's Jon Gimbel, Ph.D. on June 2

Tuesday 2 June 2020 — An FDAnews Webinar featuring R&Q
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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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News

RQM+ Remediation Station: Tools & Tips

Welcome to the Remediation Station! We've got live shows with the experts, case studies, and insights to help you get through remediation successfully.  First up, join us Friday, May 8 11:00am ET / 8:00am PT for Device Love Live #4: Best Practices for Reducing Pain in a Medical Device Remediation Program. Our subject matter experts are talking about remediation programs at medical device companies. DHF and manufacturing remediation resulting from government actions (FDA warning letters, EU's non-compliance reports) are the extreme and we know that the proactive efforts needed for many companies to achieve MDD compliance let alone the jump to MDR are no piece of cake either.   Remediation often exhausts the team, brings down morale, and leads to much debate over what is "good enough".  Let's talk about best practices to enable remediation efforts to be as pain free as possible. Join us for free by clicking the button below: Keep reading for more insight on the remediation process and what your company can do to improve your success: When do medical device companies need remediation? The need for remediation efforts at a company can be generated for a multitude of reasons. Most often it is the result of an FDA inspection or Notified Body audit that has identified numerous non-compliances. Preferably, internal audits identify areas to focus on proactive remediation efforts to avoid regulatory body findings. Established device companies typically have known deficiencies that need to be rectified or holes that need to be patched in Design History Files (DHFs), Technical Documentation, Risk Management, or Supplier Controls to name a few. No matter where you are in the range of having new-to-the-market medical devices or long-established legacy devices, you could find yourself in the situation of needing to remediate.  >> Click Here to Read a Case Study: Revamping Supplier Quality Remediation So, remediation is needed - now what? The key to successful remediation is to strategically plan your organization’s efforts. Whether remediation is conducted for proactive or reactive reasons, the tasks to address these regulatory compliance issues can be daunting. To properly achieve an effective resolution, these efforts can require numerous resources and time, potentially disrupting new product development and current operations. Most companies do not have the capacity to plan and execute remediation activities on top of the existing day to day work. We are seeing firsthand the significant resource drain and impact throughout Regulatory, Quality, and New Product Development functions at many device companies created by remediation efforts on legacy device DHFs to achieve EU Medical Device Regulation (MDR) compliance. Not conducting thorough remediation could lead to delays in your MDR certification or, in some cases, being forced to withdraw your device from the EU market. The good news is that R&Q has experts ready to go to help you successfully achieve compliance. How R&Q can help you achieve your goals Your company may have remediation experience and a strong team, but due to tight response deadlines and capacity constraints, you are struggling to adequately support the remediation effort. On the other hand, you may be going through this type of activity for the first time. R&Q’s expertise can help to drive forward any aspect of your remediation efforts. Our adaptive team can provide: >> Click Here to Learn More About R&Q's Remediation Services  Remediation Project Management - essential planning and oversight of remediation from beginning to end. Experienced Resources - our knowledgeable and experienced team members have conducted remediation efforts across many companies and types of medical devices. R&Q can support your efforts on-site or fully remote, freeing up internal resources to continue their much-needed daily operations. Subject Matter Experts – don’t have the knowledge to address issues in-house? R&Q has the expertise to guide you. Having outside eyes to review can help to identify some glaring issues and creative solutions that may not be apparent internally. Collaboration and Ownership - R&Q has a proven track record of integration into client teams to help effectively drive remediation. This collaboration ensures the effort is not just an outside entity coming in and making changes in your company. R&Q works hand in hand with our clients throughout the process to assure business agreement and ownership. Sustainable Robust Resolutions – not just stop the leak and move along …thorough investigation and gap/risk assessments to identify root causes and precise resolutions. The R&Q team will identify the issues and root cause and then work with you to make the appropriate robust changes needed to achieve compliance and avoid reoccurrence. Long Term Assurance and Support – R&Q assists in long term compliance assurance by providing periodic Internal Audit services, as well as mock audits conducted by former FDA or Notified Body auditors. R&Q can also provide appropriate training needed for internal client employees regarding compliance, regulatory requirements, and audit preparation. Regulatory & Quality Solutions (R&Q) provides best practice strategic and tactical solutions to tackle your remediation challenges. Specializing in the United States (US) and European Union (EU) regulatory and quality environments, our team can help your medical device company successfully address deficiencies and remediation efforts related to: Notified Body non-conformity reports MDD to MDR Compliance EU Technical Documentation FDA Consent Decrees, 483 Findings, and Warning Letters Complaint / Adverse Event and Device Reporting Corrective/Preventative Action Plans Internal Audit Findings Design History Files (DHF) Risk Management Programs Supplier Quality Control The R&Q team customizes the level of support needed for your remediation efforts. Whether you need a small audit or a full team to support large scale remediation, R&Q can help every step of the way. Have questions about remediation? Contact us today and check out our remediation services page for more details on how we can help.
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