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RQM+ Medical Device and In Vitro Diagnostic Blog
Topic: Webinars
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RAPS Webcast: PMCF User Feedback Surveys
on 8 April 2021 | By Stephen Biernacki
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...
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PMCF User Feedback Surveys
on 17 February 2021 | By Stephen Biernacki
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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Best Practices for Scientific Database Searching
on 18 January 2021 | By Stephen Biernacki
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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Q&A: Economic Operators - Addressing the EU MDR and IVDR requirements
on 21 October 2020 | By Nancy Morrison, RQM+
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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Integrating Risk and Complaint Management
on 16 October 2020 | By Stephen Biernacki
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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Program Management for IVDR and EU MDR
on 8 September 2020 | By Stephen Biernacki
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...
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Economic Operators: EU MDR and IVDR Requirements
on 3 August 2020 | By Stephen Biernacki
In our August 2020 webinar you'll learn about the EU MDR and IVDR requirements for economic operators.
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Q&A: Solving the EU MDR Labeling Puzzle
on 29 July 2020 | By Deven Hennon, R&Q
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...
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PMCF Plans
on 7 July 2020 | By Stephen Biernacki
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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Q&A: FDA Emergency Use Authorization (EUA) and EU MDR Article 59
on 6 July 2020 | By Deven Hennon, R&Q
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...
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Q&A: RAPS Webcast - PMS Requirements of the EU MDR
on 15 June 2020 | By Deven Hennon, R&Q
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:...
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Q&A: Structuring PERs under IVDR
on 8 June 2020 | By Deven Hennon, R&Q
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...
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FDAnews Webinar featuring R&Q's Jon Gimbel, Ph.D. on June 2
on 13 May 2020 | By Deven Hennon, R&Q
Tuesday 2 June 2020 — An FDAnews Webinar featuring R&Q
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Case Studies of MDD and MDR Audit Findings... and Lessons Learned
on 8 May 2020 | By Stephen Biernacki
On-Demand - A webinar entirely dedicated to case studies.
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Q&A: EU MDR Audits: Preparing, Managing & Responding to Nonconformances
on 28 April 2020 | By Deven Snyder
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...
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FDA Emergency Use Authorization (EUA) and EU MDR Article 59
on 27 April 2020 | By Stephen Biernacki
26 May 2020 - Processes, tips, and lessons learned.
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RAPS Webcast: PMS Requirements of the EU MDR
on 6 April 2020 | By Stephen Biernacki
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...
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Q&A: PMS Requirements of the EU MDR
on 3 April 2020 | By Stephen Biernacki
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...
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Structuring PERs under IVDR
on 1 April 2020 | By Stephen Biernacki
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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EU MDR Audits
on 5 March 2020 | By Stephen Biernacki
Preparing, managing and responding to nonconformances.
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Q&A: Developing an FDA Regulatory Strategy
on 28 February 2020 | By Stephen Biernacki
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...
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PMS Requirements of the EU MDR
on 31 January 2020 | By Stephen Biernacki
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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Developing an FDA Regulatory Strategy
on 8 January 2020 | By Stephen Biernacki
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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Solving the EU MDR Labeling Puzzle
on 17 September 2019 | By Stephen Biernacki
Our December webinar will help you understand and act on requirements.
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Strategies for Successful IVDR Implementation
on 17 September 2019 | By Stephen Biernacki
Our November 2019 webinar looked at how to assess products and more.
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FDA Updates
on 17 September 2019 | By Stephen Biernacki
Our October 2019 webinar highlighted key areas of change related to the FDA.
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EU MDR for Combination Products
on 25 March 2019 | By Stephen Biernacki
More companies will require notified body involvement.
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Top 10 EU MDR and CER Questions
on 25 February 2019 | By Stephen Biernacki
Answers to the most popular questions we receive.
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EU MDR / CER Portfolio Planning
on 25 February 2019 | By Stephen Biernacki
Know the essential EU MDR portfolio planning requirements.
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QMS for EU MDR
on 25 February 2019 | By Stephen Biernacki
Does your quality system meet the additional requirements?
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Risk Management Updates
on 25 February 2019 | By Stephen Biernacki
What to do with your process to meet the EU MDR/IVDR requirements.
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We are passionate about your success. Tell us more about your regulatory and quality needs to learn about how we can help.
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