ISO 13485

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ISO 13485 is a quality management system standard specifically designed for the medical device industry. It outlines the requirements for a quality management system that a medical device company must follow to ensure that its products consistently meet customer and regulatory requirements. This standard includes requirements for design and development, risk management, regulatory compliance, product realization, and post-market surveillance. Compliance with ISO 13485 is often a regulatory requirement for the marketing of medical devices in many countries.