ISO 13485 implementation time frame
How much time would be needed to "adjust" the toolkit to a company? I know this is not an exact science, but maybe some comments
would help. I expect you to have quite a base of users to give you some idea.
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This depends on how big is your company, is your company on one location or several; how many employees there are and how complicated are your processes. Usually, for very small companies it is necessary 2 or 3 months; small organizations up to 50 employees could implement in 6-8 months; medium-sized organizations up to 500 employees could implement in 8-12 months; larger organizations can take 12-15 months to implement.
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Mar 30, 2020