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ISO 62304

ISO 62304

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**ISO 62304**

What is ISO 62304?

ISO 62304 is an international standard specifying the life cycle requirements for the development of medical device software and software as a medical device (SaMD). It provides a framework for software development, maintenance, and risk management to ensure the safety and effectiveness of medical device software. It is commonly used by medical device manufacturers to demonstrate compliance with regulatory requirements and to improve the quality of their software.

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