Biocompatibility refers to the ability of a medical device or material to perform with an appropriate host response in a specific application. Manufacturers are required to assess the biocompatibility of their medical device by taking a holistic risk-based approach to their biological safety evaluations.

 

Biological evaluation and testing are a critical part of the regulatory approval process. 

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We can support you with:

• Training

• Gap analysis

• Change assessments (design changes, manufacturing changes etc.)

• Preparation and development of a Biological Evaluation Plan

• Preparation and development of a Biological Evaluation Report

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