QMS Aspects of the MDR (& IVDR) - BSI Group
QMS Aspects of the MDR (& IVDR) Vicky Medley Global QMS Manager –Medical Devices October 2017 1. ... (Article 110) 05 May 2017 Adoption of IVDR Entry in to Force 25 May 2017 NBs designation under IVDR ... Clause 9 –The quality management system shall address at least the following aspects: a) a strategy for regulatory compliance, including ... ................
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