on 11 January 2021 | By Deven Hennon, R&Q
We are proud to announce that R&Q and Maetrics have merged and rebranded to form the world's leading medical device and diagnostics consultancy. Check out the full press release below or visit our new brand microsite at RQMplus.com
Read Moreon 7 December 2020 | By Deven Hennon, R&Q
7 December 2020 Update: After some delays the first module of the European database on medical devices (EUDAMED) is live! Here is what you need to know about the Actor registration module, the first of six modules in EUDAMED: WHO can use this module? Economic operators...
Read Moreon 1 December 2020 | By Deven Hennon, R&Q
1 December 2020 - Getting started with Post-Market Clinical Follow-up (PMCF) Surveys under the European Union's Medical Device Regulation.
Read Moreon 28 October 2020 | By Deven Hennon, R&Q
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.
Read Moreon 14 October 2020 | By Deven Hennon, R&Q
14 October 2020 - The National Standards Authority of Ireland (NSAI) has adopted December 2020 as the expected implementation date for EN ISO 14971:2019.
Read Moreon 7 October 2020 | By Deven Hennon, R&Q
7 October 2020 - A short conversation with the European Commission provides details on when we can expect access to their expert panels.
Read Moreon 1 October 2020 | By Deven Hennon, R&Q
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.
Read Moreon 10 September 2020 | By Deven Hennon, R&Q
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 ourRAPS Convergence 2020 announcement page for more information.
Read Moreon 3 September 2020 | By Deven Hennon, R&Q
3 September 2020 - Training Workshops brought to you by the Subject Matter Experts at Regulatory & Quality Solutions.
Read Moreon 11 August 2020 | By Deven Hennon, R&Q
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.
Read Moreon 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...
Read Moreon 15 July 2020 | By Deven Hennon, R&Q
15 July 2020 - R&Q experts discuss "First Do No Harm - The report of the Independent Medicines and Medical Devices Safety Review."
Read Moreon 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...
Read Moreon 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:...
Read Moreon 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...
Read Moreon 18 May 2020 | By Deven Hennon, R&Q
As we collectively watch the world struggle to cope with the devastating impacts of COVID-19, the Emergency Use Authorization Act has given the R&Q team opportunities to provide pro bono regulatory guidance to incredible medical device companies that are prioritizing “giving...
Read Moreon 13 May 2020 | By Deven Hennon, R&Q
Tuesday 2 June 2020 — An FDAnews Webinar featuring R&Q
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