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Advanced notification of change

ISO 13485 & EU MDR
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Guest user Created:   Feb 21, 2023 Last commented:   Feb 22, 2023

Advanced notification of change

ISO 13485 & EU MDR

What should be a typical timeframe for advance notification of change to our customers?

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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 Feb 22, 2023

This depends on the significance of the change. If the change is life-threatening, this must be done immediately, or within 24 hours.  If the change is not significant, then the timeframe is up to two weeks.

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Feb 22, 2023

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