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Biocompatibility 

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:

  • 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

Ready to discuss your project?

Book a free, no obligation consultation today.