on 14 June 2022 | By Ashley Clark, MS, RAC (US, Medical Device), RQM+ Principal Specialist and Nancy Morrison, RAC, RQM+ Executive Director, Regulatory & Quality Consulting Services
Summary Genus Medical Technologies upset the US FDA classification schema for imaging agents such as barium sulfate in the landmark litigation ruling1 in the drug turned device manufacturer’s favor that only products meeting the definition of a drug must be regulated as such....
Read Moreon 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...
Read Moreon 16 February 2021 | By Ashley (Ash) Clark, MS, RAC, RQM+
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...
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