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Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
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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.
Questions? Call the RAPS Solutions Center at +1 301 770 2920, ext. 200, or email email@example.com.