Writing a Biological Safety Assessment (BSA) report: Premarketing Requ

Biological Safety Assessment or BSA as it is called is an important and wide field. As new breakthroughs by way of medicine, crop, biotechnology increase, the need to assess the safety of medical devices becomes paramount. It provides some amount of reassurance to patients in a clinical investigation. A report should be based on medical devices directives-MEDDV 2.7.1 and clinical investigations guidelines ISO 14155.


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