US, Canada Setting Trend For Global Cybersecurity Guidance

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.

major cyber attack hitting computers - Vector

International regulators have proposed an overarching medical device cybersecurity guidance that aims to set best practice principals for not only the medtech industry, but also other key stakeholders, such as health-care providers and hospital systems. The document is heavily influenced by US and Canadian regulators, which have had the most experience in developing such guidances for their own jurisdictions.

The International Medical Device Regulators Forum (IMDRF) published its first cybersecurity draft guidance on 1 October to outline its thinking on best practices when trying to ensure medical device...

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