Medivation has extensive experience in the medical regulatory field. We are capable to work either in the customer's development process or develop in our own quality system under a quality plan agreement. Furthermore, we can act as an OEM legal manufacturer for customers who do not want to approve a product on their own.
Obtaining regulatory approval
Medivation has certified medical products for CE class I, CE class IIa, FDA class 1 and FDA class 2 products as well as patient specific solutions and has supported customers to obtain regulatory approval in further markets.
- Verification and validation tasks require a deep understanding of the product risks as well as regulatory requirements. Medivation's in-house expertise can fasten the process of the V&V phase and can ensure an independent testing of critical submodules.
- Our self-developed and validated traceability tool has generated interest throughout the market for being a rather simple and straightforward working tool for traceability and document generation. More information and a free download can be found here.
Our production process meets all required regulatory requirement of ISO 13485 and allows the customer to launch inital batches for a fast market entry.