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13485 arrangements for Proof of Concept work

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Guest user Created:   Dec 15, 2020 Last commented:   Dec 16, 2020

13485 arrangements for Proof of Concept work

We have a couple of medical device products already registered with the MHRA and submitted to FDA 510K Approval but are now getting into medical device proof of concept mini projects and I want to minimize documentation requirements as these projects are short term and do not become devices. Our current medical device project paperwork is too cumbersome for these and I wonder if there are minimum requirements laid out by the standard.

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Dec 16, 2020

The minimum requirements for the ISO 13485 you can find in our ISO 13485:2016 documentation toolkit. If you go down on the linked web page, you will found a list of all documents that we have prepared.

You can see our ISO 13485 Documentation toolkit here: https://advisera.com/13485academy/iso-13485-documentation-toolkit/

Also on this link, you can find the list of mandatory documents for ISO 13485:

But, please be aware that not all requirements are applicable to all types of medical devices. So, certain documents are not applicable. For example, if your medical device is not sterile, then documentation regarding the sterilization (7.5.5 Particular requirements for sterile medical devices and 7.5.7 Particular requirements for validation of process of sterilization and sterile barrier systems) are not applicable for you. If your medical device does not require installation or service, then documentation regarding installation and service is not applicable for you (7.5.3 Installation activities and 7.5.4 Service activities).

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