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Clinical investigation of medical devices for human subjects -- Good clinical practice

Biological evaluation of medical devices Guidance on the conduct of biological evaluation within a risk management process

Biological evaluation of medical devices Guidance on the conduct of biological evaluation within a risk management process

Pyrogenicity — Principles and methods for pyrogen testing of medical devices

Biological evaluation of medical devices Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents

Cardiovascular biological evaluation of medical devices Guidance for absorbable implants

Biological evaluation of absorbable medical devices