ISO 13485, the bible of medical device management
Published on
28/05/2019,
updated
11/09/2024 à 10:54
Reading time : 1 minute
As of March1, 2019, only the latest version of the ISO 13485 standard is authoritative to show that your medical device management is beyond reproach. This version, published in 2016, takes a risk-based approach. Want to understand the standard? Training in quality auditing in this sector? Certify your management system? The AFNOR Group can help you!
> Buy NF EN ISO 13485 from AFNOR Editions
> ISO 13485 audit training with AFNOR Compétences
> Preparing for ISO 13485 certification with AFNOR Certification (french only)
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