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Dr. Andrew Tarnaris Joins RQM+ as Medical Director

RQM+ is excited to announce the addition of Dr. Andrew Tarnaris as Medical Director. With a background as both a medical doctor and notified body clinical expert, he represents an excellent example of our unique combination of clinical and regulatory experience.
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IVD | IVDR | COVID-19

EU Update: SARS-CoV-2 In Vitro Diagnostic Medical Device Performance Evaluation MDCG Guidance Published

A new guidance document (MDCG 2020-21) has been published on the 3rd of August by the Medical Device Coordination Group (MDCG) pertaining to performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices. This document provides extensive details on what is expected for SARS-CoV2 IVDs and is envisaged to form the basis for common specification to be adopted in coming months. Even if you are not making SARS-CoV-2 assays the testing details and sample sizes outlined in the guidance provide insight on the IVDR impact to technical documentation and Performance Evaluation Reports (PERs) and provide a glimpse into the level of evidence required.
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MDR | Clinical Evaluation Report

RQM+ MDR Clinical Evaluation Roadmap: An Interview with Dr. Jai Kutty

The introduction of MDR caused a major transformation in the medical device industry. Manufacturers continue to grapple with all elements of compliance, but clinical evaluation presents unique challenges. RQM+ is committed to helping clients navigate these challenges with former notified body leaders who understand what reviewers are looking for when evaluating clinical evidence.
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News

Join us at the 2021 RAPS U.S. Convergence

30 August 2021 It is that time of year again for RAPS Convergence and we cannot wait to join the largest annual gathering of regulatory professionals from around the world. The conference will be held virtually this year from 12-15 September 2021 and we will be joining in the fun with a Q&A style speaking session and a booth featuring premium expert content from this year. Learn more about our session, booth, and giveaway below and we hope to see you at RAPS Convergence in September!
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News

RQM+ Announces Investment by Linden Capital Partners

Investment to Accelerate Growth and Expand Consulting Services for Medical Device and Diagnostics Manufacturers
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EU MDR

RQM+ Case Study: Effective Managed Outsourcing for EU MDR

THE PROJECT A leading global company offering medical technology, services, and solutions engaged RQM+ to help four business units prepare for the EU Medical Device Regulation (MDR). Specifically, RQM+ is focused on assessing and remediating gaps in MDD technical files and building compliant MDR technical documentation files for submission.
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COVID-19

Crisis Survival Tip #3: Nurture Employee and Client Relationships

The past year was an extraordinary one and gave us plenty of food for thought, whether personally or professionally. At RQM+, we have been thinking about the leadership lessons we learned – RQM+ Executive VP, Lisa Casavant, recently wrote about how we managed to hold on to our employees, and RQM+ President, Maria Fagan, reflected on how the business continued to grow throughout the COVID-19 pandemic.
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COVID-19

Crisis Survival Tip #2: Stay Committed to a Strategic Vision

The past year has left us with many lessons about leadership during a crisis. From the very beginning of the COVID-19 pandemic, we made a clear intention to stick to our values as a company, though we knew this would not be a straightforward path. RQM+ EVP, Lisa Casavant, recently wrote a post about how we prioritized the retention of our people. We’re pleased that we made this decision since we were in a much better position once demand recovered.
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Safety and Performance (SSP)

An Overview of Summary of Safety and Performance (SSP) Under IVDR

EU IVDR 2017/746 includes a requirement to write a summary of safety and performance (SSP) for Class C and D IVDs. This is a new requirement that wasn’t included in IVDD. The goal of this requirement is to enhance transparency and provide adequate public access to summarized data on safety and performance to intended users, which includes both professionals and laypeople when applicable.
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COVID-19

Crisis Survival Tip #1: Hold On To Your People

As we continue to cope with the after-effects of the COVID-19 pandemic, we’ve been reflecting on the past year and how we survived as a business. Though every company should be prepared for the unexpected to happen, it is difficult to anticipate an event on the scale of a global health crisis. At RQM+ (then R&Q), we were very determined from the very beginning to preserve our values, and we’re gratified that this approach paid off. This post is part of a series sharing how we addressed some of the challenges brought about by the pandemic.
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IVDR

[Webinar] Strategies for Overcoming the Biggest Challenges in Achieving IVDR Compliance

The latest addition to our webinar series covers the biggest challenges in IVDR compliance. With hundreds of MDR submissions under our belts and a number of clients who have already received findings from their IVDR applications, we have learned a lot about the regulation, the guidance that surrounds it, and what notified bodies expect to see.
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