Our experts are available to support biological safety compliance for your device
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.
We can support you with:
Change assessments (design changes, manufacturing changes etc.)
Preparation and development of a Biological Evaluation Plan
Preparation and development of a Biological Evaluation Report