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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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News | Webinars | Q&A

Q&A: Economic Operators - Addressing the EU MDR and IVDR requirements

R&Q's August 2020 webinar focused on Economic Operators: Addressing the EU MDR and IVDR requirements head-on. In this follow-up blog post, our knowledgeable MDR and IVDR regulatory experts sat down to answer audience questions.
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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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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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News | Webinars | Q&A

Q&A: Solving the EU MDR Labeling Puzzle

Although a lot has changed in our worlds since R&Q's December 2019 webinar focused on Solving the EU MDR Labeling Puzzle, the general requirements have stayed the same. In this blog post, our knowledgeable EU MDR regulatory experts sat down to provide some updates on a few more pieces of that labeling puzzle.
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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 | Webinars | Q&A

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 | Webinars

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 | Webinars

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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Events | Webinars

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 | Webinars

Q&A: EU MDR Audits: Preparing, Managing & Responding to Nonconformances

R&Q's March 2020 webinar focused on dealing with EU MDR Audit Nonconformances. In this blog post, our knowledgeable EU MDR 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. This is only a small sample of the questions that manufacturers currently have around EU MDR audits - and there are sure to be countless others! R&Q is here to help address any other questions that you may have regarding audits or any other EU MDR related topics. Contact us today to find out how we can help! 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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Webinars

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

26 May 2020 - Processes, tips, and lessons learned.
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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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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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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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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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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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