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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.
Find out more 
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
Expert
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
Nov 06, 2021