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ISO 13485

ISO 13485 is the quality system standard for Medical Devices and related services. It is harmonized with Medical Device Directive (MDD) of CE Mark. It retains almost all quality system requirements of ISO 9001 while adding some medical device specific requirements e.g. validation of processes of sterile medical devices, promotion and awareness of regulatory requirements as a management responsibility etc.

ISO 13485 is applicable not just for medical device manufacturers but for all those who are responsible for placing the device in the market e.g. distributors, dealers, sterilization agencies etc.

ISO 13485 Advantages


	Harmonization with ISO 9001 and CE Mark Specific focus on Medical device requirements Builds Customer Confidence Standardization Reduces Costs and Overheads Brings Down Non-conformities and Risks Training and Skill Improvement

ISO 13485 Requirements


	All Major ISO 9001 Requirements Medical Device Specific Additions Product Specifications for Each Product (often referred as Technical File) Reporting Adverse Events Contamination Control

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