WebFeb 3, 2024 · A. Clinical assessment sample size - Medical device Class IIb implantable (93/42 directive) EU Medical Device Regulations. 2. Apr 7, 2024. G. New intended use - Validation of a class IIb implantable (non-active) ISO 13485:2016 - Medical Device Quality Management Systems. 5. Weband conformity assessment route chosen, devices of classification IIa and higher will need their Technical Documentation assessed by the Notified Body. This Technical …
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