Guest user Created: Jun 28, 2022 Last commented: Jun 30, 2022

13485 Implementation

My background in 13485 was within a manufacturing company that produced medical devices. I have now been tasked with implementing a 13485 QMS where there is no physical product. The offering facilities and services but no commercialised product. How would I tailor the 13485 standard to a facility and service when it is very strongly worded towards having a product?

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Kristina Zvonar Brkić Jun 30, 2022

In section 1 Scope of the ISO 13485:2016 is stated that this standard is both for the medical device and related services. So, yes it is possible to implement ISO 13485 for providing the service. The best approach to this situation is that wherever you see the word production, read it as service. So when you will go through 7.5 Production and service provision, just look at it from the aspect of service provision.

Of course, certain requirements will not be applicable to your company, therefore, you will not prepare any documentation for these requests (like for sterilization, installation, or work environment, and so on).

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Jun 27, 2022

Jun 30, 2022

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