MedTech Europe. Clinical Evidence Requirements for CE certification under IVDR
Accredited Notified Bodies under MDR
Accredited Notified Bodies under IVDR
ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes
ISO 14971:2007 Medical devices — Application of risk management to medical devices
ISO 10993-1:2018 Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
ISO 14155:2020 Clinical investigation of medical devices for human subjects — Good clinical practice
MDCG endorsed documents and other guidance relevant to MDR and IVDR
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