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ISO 13485 implementation

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Guest user Created:   Oct 20, 2020

ISO 13485 implementation

1. As we are a low-risk class I one medical device manufacturer, if we want to declare our conformity according to MDR do we also need to comply with all the applicable harmonized standards like (ISO 13485, ISO 14971, IEC 60601-1-2) ? Or are these standards optional for class I?

2. Do we need ISO 13485 or other certification from an accredited body? 

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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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Oct 20, 2020

Oct 20, 2020

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