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March 2025
The Best Practices Guide for Medical Device Cybersecurity provides key recommendations to enhance the security of medical devices throughout their entire product lifecycle (TPLC), covering both pre-market and post-market stages.
The guide emphasizes the importance of clear user manuals, security guidelines, troubleshooting support, and software/firmware update instructions to ensure device security. It highlights the role of the Software Bill of Materials (SBOM) in tracking software components, identifying vulnerabilities, and maintaining a secure medical device ecosystem.
Post-market activities such as monitoring, vulnerability disclosure, patching, and information sharing are essential to addressing security issues after a device is introduced to the market. The guide outlines different stages in the TPLC of a medical device, including Support, Limited Support, and End of Support, detailing the responsibilities of manufacturers and healthcare providers at each phase.
Cybersecurity is a shared responsibility between device manufacturers and healthcare providers, requiring continuous monitoring, risk assessment, and mitigation throughout the device’s lifecycle.
Region: South East Asia
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