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Excluding Clause 7.3 (Design and development) from QMS

ISO 13485 & EU MDR
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Guest user Created:   Feb 21, 2022 Last commented:   Feb 22, 2022

Excluding Clause 7.3 (Design and development) from QMS

ISO 13485 & EU MDR
in what cases is it possible to exclude Clause 7.3 (Design and development) from QMS?
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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, 2022

If you do not develop completely new products or new services, then it is possible to exclude requirement 7.3. In other words, any change or adaptation of the product, creation of a new version of the product, or development of a new service means that requirement 7.3 is applicable.   

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