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ISO 14971 Risk Management Consulting for Medical Devices
ISO 14971 Risk Management Consulting helps medical device manufacturers establish, implement, and maintain an effective risk management process throughout the entire product lifecycle. ISO 14971 is the international standard that defines how to identify hazards, estimate and evaluate risks, control those risks, and monitor the effectiveness of controls to ensure patient safety and regulatory compliance.Our ISO 14971 consulting services support organizations in building a structured, compliant risk management framework that aligns with global regulatory requirements, including FDA, EU MDR, and other international authorities.
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