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IVDR | ivdr CE marking

How to Obtain CE Marking Under the IVDR

CE marking is the system used in the EU to indicate that products meet the region’s safety, health, and environmental protection requirements. Products labeled with the CE marking can be freely traded in the European Economic Area without restrictions.
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SSCP Requirements

8 Lessons Learned After Writing the Summary of Safety and Clinical Performance (SSCP) using MDCG 2019-9

EU MDR 2017/745 includes a requirement to write a summary of safety and clinical performance (SSCP) for implantable and Class III devices. Although this is still a relatively new requirement, RQM+ has already gained valuable experience preparing SSCPs on behalf of our clients. If you’re starting the process of creating your SSCPs, this post covers the basics and some lessons learned from our own experience.
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Webinars

RAPS Webcast: PMCF User Feedback Surveys

Update: the RAPS + RQM+ webcast is now available on demand here. Understand the ins and outs of PMCF user feedback surveys by registering for two upcoming and free RQM+ webinars: April 27 – PMCF User Feedback Surveys: Practical solutions for leveraging user feedback surveys as PMCF activities under the EU MDR (60 minutes) (register here) May 18 – PMCF User Feedback Surveys: Practical Solutions, Lessons Learned, and Processes for Success (features activity to develop a survey in real-time, 90 minutes, 1.5 RAC credits) (now available on demand)
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Webinars

PMCF User Feedback Surveys

In this webinar we will provide practical solutions for leveraging user feedback surveys as PMCF activities under the EU MDR, presented by former notified body leadership and PMCF subject matter experts.
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IVDR

MDCG 2020-16 Classification Guidance for IVDs

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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News

Dr. Jaishankar Kutty Joins RQM+

February 1, 2021 - RQM+ welcomes Dr. Jai Kutty.
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News

New Guidance: FDA Safer Technologies Program (STeP) for Medical Devices

U.S. Food & Drug Administration (FDA) released the highly anticipated Safer Technologies Program (STeP) Guidance Document.
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Webinars

Best Practices for Scientific Database Searching

This on-demand webinar will address best practices in scientific database search techniques that can be applied in the performance of a clinical evaluation.
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News

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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News

Leveraging PMCF Surveys for EU MDR Compliance - Part 2

When to use Post-Market Clinical Follow-up (PMCF) Surveys under the European Union's Medical Device Regulation.
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News

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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News

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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