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
Unitron Regulatory offers support in building your technical documentation and meeting obligations in order to bring your medical device or life science device to the market.
From experience gained from multiple product dossiers, we thoroughly understand the European regulatory framework for active medical devices (MDD/MDR), the obligations set out for all key players in the device’s life cycle, and the challenges many parties face.
Whether you are new to the industry or already experienced in this field, regulatory demands can be overwhelming.
Once on the market, a manufacturer is required to keep his product, its accompanying documents and technical documentation ‘state of the art’.
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