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MDCG 2020-16 Classification Guidance for IVDs

February 16, 2021 - RQM+ experts summarize the MDCG guidance from November 2020, Guidance on Classification Rules for the in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746, to aid IVD industry stakeholders in understanding, planning, and executing compliance to the IVDR by May 2022. The examples in the blogpost are not intended to be exhaustive of all scenarios of applicability.
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Dr. Jaishankar Kutty Joins RQM+

February 1, 2021 - RQM+ welcomes Dr. Jai Kutty.
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New Guidance: FDA Safer Technologies Program (STeP) for Medical Devices

January 21, 2021 - U.S. Food & Drug Administration (FDA) released the highly anticipated Safer Technologies Program (STeP) Guidance Document.
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Announcing RQM+

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
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Leveraging PMCF Surveys for EU MDR Compliance - Part 2

15 December 2020 - When to use Post-Market Clinical Follow-up (PMCF) Surveys under the European Union's Medical Device Regulation.
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EUDAMED Delay Brings Little Comfort to Medical Device Companies

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 (manufacturers, authorized representatives, importers, system procedure pack manufacturers) can now register. Note: United Kingdom (UK), Turkey, and Switzerland cannot yet. WHAT can they do? Obtain Single Registration Number (SRN) WHY is this important? The SRN is required to appear on the Declaration of Conformities (DoCs) and numerous other documents affecting all classes of medical devices. WHEN can they do it? If the company is located outside the European Union (EU), the authorized representative must register first but registration is open. HOW do I get started? Find the instructions, FAQs, and various supporting information on the European Commission's website here.  For R&Q clients that have been waiting to obtain their SRN to finalize their Summaries of Safety and Clinical Performance (SSCP), DoCs, and have TBDs in their technical documentation, this allows them to move forward.  >> Access On-Demand Webinar: Economic Operators - Addressing the EU MDR and IVDR requirements Originally published 21 November 2019, updated to reflect new MDR date of application:  The European database on medical devices (EUDAMED) has officially been delayed until May 26, 2022! Due to COVID-19 pandemic, the date of application of the MDR has been delayed to May 2021, though you don’t need us to remind you that is right around the corner! Fortunately, a potential delay in the database was anticipated and provisions for a delay are outlined in the regulation that can be found on the European Commission’s page on EUDAMED here. So, what does the EUDAMED delay mean? Article 123 (3)(d) lists all the derogations that occur with a delay in the database until six months after notice in the Official Journal of the European Union that the database is available. One caveat to that notice is that the sections that are delayed are those provisions “that relate to EUDAMED”, meaning that you will still need to create a Periodic Safety Update Reports (PSUR) per the EU MDR schedule even if it does not have to be uploaded into EUDAMED. The conclusion paragraph from the section on derogations points to provisions to take until EUDAMED becomes available in 2022. It points to the use of existing Medical Device Directive (MDD) communication methods and this works for registrations, clinical investigations, and vigilance reporting as those provisions are existing systems in the MDD. However, it leaves out how new requirements will be covered during the interim from the date of application of the regulation to the implementation of EUDAMED. There is no clarification offered for new elements such as the Safety and Clinical Performance Reports (SSCP) and the PSUR.
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Leveraging PMCF Surveys for EU MDR Compliance - Part 1

1 December 2020 - Getting started with Post-Market Clinical Follow-up (PMCF) Surveys under the European Union's Medical Device Regulation.
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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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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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Top Ten Tips and Best Practices for PMCF Surveys Under EU MDR

10 November 2020 - R&Q 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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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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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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