By: Ryan Randall, Senior Engineer, RQM+ (former FDA CDRH Lead Reviewer) and Kevin Go, Project Engineer, RQM+ (former FDA CDRH Lead Reviewer)
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IVD | COVID-19
EU Update: Expert Panel Views for SARS-CoV-2 Devices
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 criticality of these devices, these expert panel views are a big milestone to speed up conformity assessment work conducted by notified bodies (NB) to achieve In Vitro Diagnostic Regulation (IVDR) CE marking.
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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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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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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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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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