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Biosafety and In-Vitro Diagnostics

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In-Vitro Diagnostic Devices

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 set general biosafety and performance requirements for designing and verifying in-vitro diagnostic medical devices. Our experts have the knowledge and experience to help you plan, test, and document compliance with all regulatory requirements and get your product to market.

Check out how we can help here.