"Demystifying Regulatory Requirements: 21 CFR 820 vs. ISO 13485"
21 CFR 820 and ISO 13485 are two distinct sets of Quality Management System (QMS) standards that are relevant to the medical device industry. While they share some similarities, there are also notable differences between them. Here's a comparison: 21 CFR 820 (FDA Quality System Regulation): 1. Applicability: 21 CFR 820, also known as the FDA Quality System Regulation (QSR), is specific to the United States and is enforced by the U.S. Food and Drug Administration (FDA). It applies to manufacturers of medical devices sold in the U.S. 2. Legal Requirement: Compliance with 21 CFR 820 is a legal requirement for companies manufacturing medical devices in the United States. Non-compliance can result in regulatory actions and even product recalls. 3. Scope:21 CFR 820 covers a wide range of requirements for the design, manufacturing, labelling, packaging, distribution, and post-market surveillance of medical devices. It also includes requirements for recordkeeping and complaint ha...