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Our new ISO 13485:2016 certificate is available!

18/09/2022

Our new ISO 13485:2016 certificate

ISO 13485:2016 certificate

The certificate marks the end of the transition from Lloyds Register to our new Notified Body Dekra Certification GmbH.

This is a major step in our compliance with Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices. The scope of our activities remains unchanged.

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Disclaimer: this information is indicative and subject to change without prior notice. Use the documentation included with the products.

If in doubt, contact us.