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 servicesUnitron Regulatory offers support in building your technical documentation.
We know about the EU regulatory framework for active medical devices.
New to the industry or experienced? Either way, regulatory demands can be overwhelming.
Once placed on the market, the product and its documents shall stay '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 MDRDo you have a question about our regulatory services? Please get in contact with us.
Contact us Unitron Regulatory
+31 (0)117 307 300
regulatory@unitron.nl
Unitron Systems B.V.
+31 (0)117 307 300
info@unitron.nl
Asveldweg 2
7556 BP Hengelo
GOOGLE MAPS
Schansestraat 7-9
4515 RN IJzendijke
GOOGLE MAPS
Unitron Regulatory
Asveldweg 2
7556 BP Hengelo
+31 (0)117 307 300
regulatory@unitron.nl
GOOGLE MAPS
Unitron Systems b.v.
Schansestraat 7-9
4515 RN IJzendijke
+31 (0)117 307 300
info@unitron.nl
GOOGLE MAPS
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