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so 13485 certification (1st Jan 26 at 3:03am UTC)
ISO 13485 certification confirms that a medical device manufacturer has implemented a Quality Management System that meets global regulatory requirements for safety, effectiveness, and consistency. It focuses on risk management, documentation, process control, and regulatory compliance throughout the product lifecycle. Achieving ISO 13485 certification builds customer trust, supports market entry in major regions, and helps ensure medical devices meet the highest quality and safety standards.

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