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Unitron Regulatory

Your reliable partner for medical device certification support and advice

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.

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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