The guidance well explained the application of the risk management process for biocompatibility evaluation which is one of the pillar of ISO-related regulation for biocompatibility evaluations of medical devices. This guideline shall be used to support pre-market approval submission for the part related of biocompatibility evaluation. The topic that will be covered in this post is focused on the Risk Management Approaches for Biocompatibility Evaulation.įDA recently published an extensive guidelines in the interpretation of International Standard ISO 10993-1, “ Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process”. The goal of this article is to provide a high-level overview of approach that can be used for the validation of medical devices from biocompatibility point of view. It is an important process during the design of the device that has a fundamental impact in the regulatory clearance or approval of the device by regulatory agencies or notified bodies.īiocompatibility evaluation for medical devices is a very broad topic which can be faced from different angles. Biocompatibility, Design Validation, ISO 10993īiocompatibility evaluation according to ISO 10993-1 and the related biological risk assessment is one of the most important validation activities for medical device.
