21 CFR Part 820 vs ISO 13485:2016 for Medical Device Quality Management Systems

 


Quality Management Systems-QMS play a crucial role in ensuring the safety and effectiveness of medical devices. This paper presents a comprehensive comparative analysis of two major regulatory frameworks, 21 CFR Part 820 (FDA's Quality System Regulation) and ISO 13485:2016 (International Organization for Standardization's Medical Devices - Quality Management Systems), which govern QMS requirements for medical device manufacturers. The abstract explores the key similarities and differences between these standards, including scope, documentation, risk management, design controls, and post-market surveillance. By understanding the nuances of both regulations, medical device manufacturers can effectively navigate the global marketplace, comply with relevant standards, and provide safe, high-quality products to patients and healthcare professionals.

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21 CFR Part 820 vs ISO 13485 | Compliance Group Inc


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