Our team has specialist knowledge and practical experience with regard to product certification (CE, MDD/MDR, IVDD/IVDR, LVD, FDA, etc.) of medical and life-science electronic products and equipment. We are experts in the field of building up a technical product file and product life cycle management.
Unitron Regulatory offers support in building your technical documentation.Read more
We know about the EU regulatory framework for active medical devices.Read more
New to the industry or experienced? Either way, regulatory demands can be overwhelming.Read more
Once placed on the market, the product and its documents shall stay 'state of the art'.Read more