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Earlier capture

Draft Guidance Document - Pre-market Requirements for Medical Device Cybersecurity - Canada.ca

Apr 18, 2025

legacy-hc-2025-04-21

ID 141448

Later capture

Draft Guidance Document - Pre-market Requirements for Medical Device Cybersecurity - Canada.ca

Jan 2, 2026

hc-20260101

ID 428649

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: A plan describing the activities the device, manufacturer or user must undertake to restore the device to normal operating capacity following a cybersecurity event. The outcome of any investigations into previous recoveries may be used as feedback into the risk management process.
The framework is intended to complement the ISO 14971 risk management processes. A medical device manufacturer with a mature cybersecurity risk management process is encouraged to utilize the concepts of the framework to identify areas in its cybersecurity risk management processes that can be improved. A manufacturer that does not have an established cybersecurity risk management process may consider using the framework as a guide to establish organizational best practices in the cybersecurity of the devices that they manufacture.
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-Date modified:
2020-12-10