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ISO 13485 - Medical Devices

ISO 13485 is an International Organization for Standardization (ISO) standard for a comprehensive quality management system for the design and manufacture of medical devices.

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ISO 13485 is a standard for a comprehensive quality management system for the design and manufacture of medical devices. This standard emphasizes risk management, maintaining effective processes, and meeting regulatory and customer requirements.

Organizations do not need to be actively manufacturing medical devices or their components to seek certification to this standard. ISO 13485 certification can also be the first step in achieving compliance with European regulatory requirements.

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