Quality Management System – Medical Devices – Guidance on the Control of Products and Services Obtained from Suppliers

Quality Management System – Medical Devices – Guidance on the Control of Products and Services Obtained from Suppliers

Guideline

This guidance document is intended for medical device manufacturers and it is expected that the reader is familiar with regulatory quality management system requirements within the medical devices sector. This guidance document may also be useful to regulatory authorities and suppliers. This guidance document is intended for educational purposes and it is not intended to be used to assess or audit compliance with regulatory requirements.