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Common QMS Mistakes SaMD Companies Make

Global Medical Device Podcast powered by Greenlight Guru

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Is ISO 13485 Specification Different From En?

ISO 13485 is international. EN is for Europe and BSE for Great Britain. Those are the standards that you want to be following. The standard differences is something known as Z-anaxes. It just aligns with the regulatory requirements of the region that you're working in. That's all it is. But you want to make sure that you are following the regulatory requirement because ISO 13485 does state that.

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