21 CFR 820 Quality System Regulation and ISO 13485 Medical Devices (On-Demand)

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21 CFR 820 Quality System Regulation and ISO 13485 Medical Devices (On-Demand)

This is the On-demand recording of The RAPS Philadelphia Chapter’s webcast covering 21 CFR 820 quality system regulation and ISO 13485 medical devices.

All medical device manufacturers supplying medical devices to the US are required to maintain a quality management system in compliance with the Code of Federal Regulations (CFR) Title 21, also known as 21 CFR 820. The quality management system requirements cover a broad range of areas, including production and process controls, corrective and preventive actions, product development and management.

 The ISO 13485 standard is an effective solution to meet the comprehensive requirements for a quality management system. Adopting ISO 13485 provides a practical foundation for manufacturers to address the Medical Device Directives, regulations and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices.


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