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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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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

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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News

R&Q's Ruthanne Vendy Contributes to RAPS Fundamentals of EU Regulatory Affairs

11 August 2020 - We sat down to with R&Q's Ruthanne Vendy, RAC to talk about her experience as a contributing author to the Regulatory Affairs Professionals Society’s (RAPS) Fundamentals of EU Regulatory Affairs, Ninth Edition.
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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

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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News

First Do No Harm: Protecting Patients Through Post-Market Surveillance

15 July 2020 - R&Q experts discuss "First Do No Harm - The report of the Independent Medicines and Medical Devices Safety Review."
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