RQM+ Medical Device and In Vitro Diagnostic Blog

FDA | COVID-19

How to Prepare for COVID-19 EUA or Enforcement Policy Expiration

on 22 February 2022 | By Ryan Randall, Senior Engineer, RQM+ (former FDA CDRH Lead Reviewer) and Kevin Go, Project Engineer, RQM+ (former FDA CDRH Lead Reviewer)

Since the beginning of the COVID-19 pandemic, CDRH has dealt with an unprecedented workload to ensure timely access to high quality health products that are essential to the nation’s pandemic response. Two years later, the pandemic response remains a top priority as CDRH...
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IVD | COVID-19

EU Update: Expert Panel Views for SARS-CoV-2 Devices

on 2 February 2022 | By Heike Moehlig-Zuttermeister, PhD, RQM+ VP Intelligence and Innovation, IVD

The first three Performance Evaluation Consultation Procedure (PECP) views have been published for a professional SARS-CoV-2 immunoassay and a professional nucleic acid testing (NAT) assay as well as a near-patient testing NAT SARS-CoV-2 product. Considering the actual...
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IVD | IVDR | COVID-19

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

on 13 September 2021 | By Ashley (Ash) Clark, MS, RAC, RQM+

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...
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COVID-19

Crisis Survival Tip #3: Nurture Employee and Client Relationships

on 16 July 2021 | By Steve Cottrell, RQM+ Executive VP, Global Commercialization

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...
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COVID-19

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

on 2 July 2021 | By Maria Fagan, RQM+ President

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,...
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COVID-19

Crisis Survival Tip #1: Hold On To Your People

on 25 June 2021 | By Lisa Casavant, RQM+ EVP

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...
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