Do you manufacture in-vitro diagnostic medical devices? If so, you will need a CE Mark certificate to market them in the EU. A CE certificate verifies the biosafety of your products and that they perform as intended. Regulations such as (EU) 2017/746 (IVDR) Annex I...
After more than a year of dedicated effort and nearly 4.000 hours of preparation, we are proud to announce that we have received the globally recognised ISO 13485:2016 certification from BSI under certificate number MD725842. We chose BSI as our certification partner...
