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Incorporation of conformity assessment in QMS

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Guest user Created:   May 29, 2020 Last commented:   May 29, 2020

Incorporation of conformity assessment in QMS

I have been asked how conformity assessment can be incorporated in QMS?
Could you help me with this, please?

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ISO 13485 DOCUMENTATION TOOLKIT

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić May 29, 2020

Conformity assessment is a process that is used to demonstrate that a product meets specified requirements. In the case of medical devices, it means that conformity assessment is a process of demonstrating whether the requirements of MDD (93/42/EEC) or MDR (2017/745) relating to the device have been fulfilled. So, all documentation, tests, and reports according to the applicable regulations need to be done. It means that you need to define your processes in the way to collect all of it. 

Here you have a direct link to Annex 9 of the MDR

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May 29, 2020

May 29, 2020