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Mock examples

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Guest user Created:   Nov 04, 2021 Last commented:   Nov 06, 2021

Mock examples

my question is we presently do not have business requiring 13485 however our registrar expects we have examples. We have many medical parts and more to come after we are certified.. I plan to set up a mock examples of how we would handle medical devices with the current parts we have. do you feel this is a good approach to demonstrate our readiness?
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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 Nov 06, 2021

Yes, I agree with this approach. The point here is that you need to prove that you have a system in place, and that system is applicable for any type of medical device or component.

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Nov 04, 2021

Nov 06, 2021

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