International Regulators Issue Final Cybersecurity Guidance
A final IMDRF guidance on medical device cybersecurity reinforced US and Canadian regulatory thinking on issues such as a total product life cycle approach, shared responsibility and creating a software bill of materials.
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A draft IMDRF guidance released this month aims to set the trend for how regulators around the world oversee cybersecurity of medical devices. According to experts, the document also foreshadows what sponsors can expect from the US FDA in areas such as developing a software bill of materials, as the agency updates its own cybersecurity guidances.
The tools include new laboratory methods, and computational models and simulations give the agency more capabilities to test and validate data in premarket submissions.