Just one question: which of these options suits you best?



Download

Unitron Regulatory

Unitron Regulatory is the right partner for product certification in the field of medical devices and life-science devices. 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.

Discover our services

Our services

Unitron Regulatory is the right partner for product certification in the field of medical devices and life-science devices. 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.

UPDATE MDR

The MDR is postponed and the new date of application is 26th May 2021. As a gesture to the medical device industry we would like to provide our own ‘readable’ version of the updated MDR.

Download readable MDR