ISO/TR 80002-2

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ISO/TR 80002-2:2017 - Medical device software — Part 2: Validation of software for medical device software applications

ISO/TR 80002-2:2017 provides essential guidelines for validating software used in medical devices, ensuring compliance with both regulatory and safety standards. It emphasizes the importance of integrating validation into every phase of the software life cycle and ensuring continuous monitoring and risk management, particularly as software updates or changes are made. By following the recommendations in this technical report, manufacturers can improve the safety, efficacy, and regulatory compliance of medical device software, ultimately benefiting both healthcare professionals and patients.