Module 14: Design Development and Certification of Medical Devices

17/11/2023

Quality Management System

2 parts: • Overall Quality Management System procedures • QMS Device-specific information

Includes summary of procedures in place to ensure manufacture, change control, safety monitoring are in place ISO 13485 compliance

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Declaration of Conformity

Document that is signed to confirm that based on the information presented in the STED, the Device:

• Complies with the GSPR

Device is therefore fit for purpose

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