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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 | Live!

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 | 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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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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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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EU MDR

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 | 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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