Quality Management System implementation acc. to Medical Device Regulation

Medical Device

11/23/2023

Seminar how to implement the ISO 13485 norm into the QMS system, in conformity with the Medical Device Regulation:

• ISO 13485:2016
• Economic operators acc. to MDR
• Requirements for labelling, IFU
• Requirements for PMS
• Requirements for PMCF
• Conformity of marketing material
• Liability
• Unique Device Identification

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