IDEVAX is ISO 13485:2016 certified

We are very proud to announce that IDEVAX is ISO 13485:2016 certified. The certificate has been issued by notified body ECM. IDEVAX is now certified for its quality management system covering the design and development, production, and making available of single-use medical devices for invasive transient injection in the skin.

ISO certificate

We continue our journey in assuring the supply of high quality medical devices, including our VAX-ID device platform. Obtaining the ISO 13485:2016 certificate is important milestone and confirmation of our legacy.

Read more about the ISO 13485:2016 here  ISO 13485:2016 – Medical devices — Quality management systems — Requirements for regulatory purposes

Feel free to tune in for the short movie ‘Let’s talk quality and regulatory‘ by our QA and RA Manager, Daniele Scalco Vasconcelos.

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