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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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
- Conformity assessment based on a quality management system and assessment of the technical documentation: https://advisera.com/13485academy/mdr/conformity-assessment-based-on-a-quality-management-system-and-assessment-of-the-technical-documentation/
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May 29, 2020