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FDA announced its recognition of a key consensus standard to address cybersecurity concerns (From Catapult’s regulatory round-up – November 2023)

The FDA has announced its recognition of a key consensus standard to support device sponsors as they address cybersecurity concerns. ANSI/AAMI SW96:2023 Standard for medical device security – security risk management for device manufacturers provides specific requirements for managing security across a product’s entire life cycle. Published by the American National Standards Institute, Inc., and the Association for the Advancement of Medical Instrumentation, the Recognized Consensus Standards: Medical Devices aligns with existing international safety risk management standards and quality systems expectations. It also provides direction to sponsors on how to consider and address cybersecurity risks in device design and development. The FDA recommends the use of this new standard to enhance quality and support product performance.

Published on the 5th of december 2023. Read Catapult’s full regulatory round-up here.


OpenEdition vous propose de citer ce billet de la manière suivante :
adelage (21 mai 2024). FDA announced its recognition of a key consensus standard to address cybersecurity concerns (From Catapult’s regulatory round-up – November 2023). ELSIBI. Consulté le 18 février 2025 à l’adresse https://doi.org/10.58079/11p06


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