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Lessons Learned: 2020 RAPS U.S. and Euro Convergence

RQM+ sponsored both RAPS U.S. and Euro Convergence conferences in 2020 and we also led and provided subject matter experts for two panel discussions. Our experts pulled together the highlights from both conferences and summarized them by category for our readers.
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News

A New Approach to Corporate Holiday Gift Giving

18 November 2020 - A challenging year makes it more important than ever to be supporting and serving our communities.
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News

Top Ten Tips and Best Practices for PMCF Surveys Under EU MDR

10 November 2020 - RQM+ experts have come up with a list of our top ten suggestions for mastering Post-Market Clinical Follow-up ("PMCF") Surveys under the European Union's Medical Device Regulation.
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News

FDA’s Tool for Assessing Medical Device Cybersecurity Vulnerabilities

28 October 2020 - October is National Cybersecurity Awareness month, so we think there is no better time to talk about FDA’s new qualified tool for assessing medical device cybersecurity vulnerabilities and why using it makes sense to help you #BeCyberSmart.
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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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News

Irish Notified Body Requires ISO 14971:2019 Compliance by December 2020

14 October 2020 - The National Standards Authority of Ireland (NSAI) has adopted December 2020 as the expected implementation date for EN ISO 14971:2019.
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News

A Discussion With the European Commission on Expert Panels

7 October 2020 - A short conversation with the European Commission provides details on when we can expect access to their expert panels. 
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News

What You Need to Know About the UK's New Medical Device Guidance

1 October 2020 - As the end of the BREXIT transition period nears, the UK government has released a proposed regime on the regulation of medical devices.
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News

R&Q Acquires Maetrics to Form the Largest Medical Device-Focused Global Regulatory and Quality Consultancy

We are proud to announce that we have acquired Maetrics, a leader in life sciences quality and regulatory consulting. Check out the full press release below or visit our RAPS Convergence 2020 announcement page for more information.
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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

Announcing R&Q Training Workshops

3 September 2020 - Training Workshops brought to you by the Subject Matter Experts at Regulatory & Quality Solutions.
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