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Excluding Clause 7.3 (Design and development) from QMS
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.
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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
Expert
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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