FDA Cybersecurity Safety Communication

FDA issued a safety communication: Cybersecurity for Medical Devices and Hospital Networks. This notices is intended for hospitals, user facilities, health care IT and procurement staff and biomedical engineers.
It indicates FDA has become aware of vulnerabilties and incidents where medical devices have been affected by malware and timely security software updates have not been provided or installed. FDA is not aware of actual patient injuries.

This communication recommends a number of actions. The full text is at the link provided.

SoftwareCPR Training Courses

IEC 62304 and Emerging Standards Impacting Medical Device and HealthIT Software

ISO 14971 Risk Management (typically with heavy emphasis on software aspect)

IEC 81001-5-1 Cybersecurity Lifecycle

ISO 13485 QMS Requirements & optionally ISO 19011 for leading audits

Being Agile Yet Compliant (AAMI TIR 45)

IEC 29119-1 Software and System Testing

US Classification for Software Devices

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

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