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Certification Requirements

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Guest user Created:   Apr 26, 2023 Last commented:   May 17, 2023

Certification Requirements

Are there any specific requirements for which certification bodies we use for ISO 13485? In IATF it mentions the certification body needs to be accredited by an IAF MLA member.

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ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Apr 26, 2023

Yes, if you want to have valid certificates for markets all over the world, your certification body must be accredited by IAF. Otherwise, it may happen that you will not be able to enter a certain market because your certification body will not be recognized.

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Guest user May 16, 2023

ISO 13485 clause 4.2.3 specifies a requirement for a medical device file. Does Advisera have a template or an example that could be referenced?

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Kristina Zvonar Brkić May 17, 2023

We have prepared the template for Technical documentation that is requested in Annex II of the MDR 2017/745. This document is much broader than is requested by ISO 13485:2016 but can be a guide if necessary.

The question here is are you a manufacturer, distributor, or some other business entity? If you are a manufacturer, for the EU market, your medical device file must be totally in compliance with the Annex II and Annex III of the MDR 2017/745. If you are a distributor or some other business entity then it is enough to have in the Medical device file what is written in the standard.

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