CLINICAL AFFAIRS
Need support with Clinical Evaluation or Clinical Studies?
Clinical Evaluation is the final validation of a medical device to confirm that the device performs as intended and can safely be used in patients in accordance with its instructions for use. Worldwide regulatory requirements prescribe how such Clinical Evaluation needs to be completed. Specific regulatory requirements regarding Clinical Evaluation exist for example, in the US, EU, and China. Key principles of Clinical Evaluation are the same in the different regulatory regions.
"I strongly believe in the value of a practical and user-friendly approach while ensuring a high standard of quality. I look forward to helping customers bring their products to the market efficiently in an increasingly demanding regulatory environment. Does your medical device lack clinical data? We can help determine how to efficiently close those gaps and support your clinical investigations."
- Wiebe Postma, Clinical Investigation Expert