Latest NEWS: MDCG Guidance on Questions and Answers on vigilance terms and concepts as outlined in MDR +++ Notified Body: BSI Medical Device Regulation mapping guide +++ Latest DOCUMENT in our Library: CEN and CENELEC Work Programme 2023 +++ IVDR/MDR PRRC Job Description/Designation Letter in STORE now +++ WEBINAR on differences between EU IVDR and CH IvDO+++ Our memberships give access to our comprehensive Library of documents, News section, regulatory alerts,...
Latest NEWS: MDCG Guidance on Questions and Answers on vigilance terms and concepts as outlined in MDR +++ Notified Body: BSI Medical Device Regulation mapping guide +++ Latest DOCUMENT in our Library: CEN and CENELEC Work Programme 2023 +++ IVDR/MDR PRRC Job Description/Designation Letter in STORE now +++ WEBINAR on differences between EU IVDR and CH IvDO+++ Our memberships give access to our comprehensive Library of documents, News section, regulatory alerts,...

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Did you know that QMS as per ISO 13485:2016 requires to have a system in place to monitor relevant regulatory requirements and related changes ?
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