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Supplier to a medical device company

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Susan Created:   Mar 23, 2023 Last commented:   Mar 26, 2023

Supplier to a medical device company

We supply components to medical device companies but actually do not make a medical device.  We are ISO 13485 because we choice to be not because we had to be.  Are we required to maintain a Medical Device File?

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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 Mar 26, 2023

Yes, this requirement is mandatory for all companies that have implemented ISO 13485. But, of course, you will adapt it to your situation. This means that you will have as a part of the medical device file:

    a) a general description of the medical device, what is its purpose - how it is a part of the final medical device, how you label that device, and how it is implemented in the final medical device (if you know it)
    b) specifications for the product
    c) specifications or procedures for manufacturing, packaging, storage, handling, and distribution
    d) procedures for measuring and monitoring
    e) as appropriate, requirements for installation
    f) as appropriate, procedures for servicing.

So, you will be concentrating only on your device, not the final medical device.

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Mar 23, 2023

Mar 26, 2023