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ISO 13485 Documentation & implementation

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Guest user Created:   Jul 15, 2020 Last commented:   Jul 17, 2020

ISO 13485 Documentation & implementation

I want to ask that ,is ISO all documentation is same for disposable medical device & IVD or any change in IVD ?

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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 Jul 17, 2020

If I understand the question correctly, you are asking is ISO 13485:2016 quality management system documentation the same for disposable medical devices and IVD devices. Yes, basic documentation is the same, the only difference is the procedures and work instructions for the production process (what kind of the production it is, is it necessary to produce them in the cleanroom or not, is there a sterilization process involved and similar).

For more details which documents are mandatory for ISO 13485:2016, please see the following links:

On the following link, you can see how our ISO 13485:2016 documentation toolkit looks like - https://advisera.com/13485academy/iso-13485-documentation-toolkit/

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Jul 15, 2020

Jul 17, 2020