Biocompatibility
Biocompatibility issues are becoming more and more frequently questioned from regulators. In order to obtain the necessary approvals for the various markets it is vital to understand and interpret the regulatory requirements correctly both locally and globally
To achieve required results, strategic planning from the beginning of the development process together with a good knowledge about materials and regulatory requirements is necessary. This is one of the most common problems to delay clearance or approval in FDA-submissions.
We help you manage the biocompatibility assessment of your products through the whole development process by:
- Identifying specific requirements and regulations for the intended markets.
- Literature search and evaluation
- Determining the strategy and implementation of the biocompatibility testing
- Evaluating and summarizing the test results
- Establishing and maintaining a biocompatibility file
Through the extensive experience in our team and network (Japan & USA) we can combine an in depth knowledge of international standards with the experience of regulatory requirements on different markets.
This combination, together with the implementation of biocompatibility testing at WuXi AppTec, will provide you with unique support and help through the whole process from prototype to finished product.