The US FDA announced on December 21, 2021, a cybersecurity alert for the Fresenius Kabi Agilia Connect Infusion System. The announcement referenced a Cybersecurity and Infrastructure Security Agency (CISA) publication of a vulnerability disclosure ICSMA-21-355-01 on the Fresenius Kabi Agilia Connect Infusion System. Successful remote exploitation of these vulnerabilities could allow an attacker to gain...Read More
Updated Risk Management training course now available. Includes:
Coverage of ISO 14971, IEC 62304; amd1, and IEC/TR 80002-1.
Why FMEA is incomplete for medical device risk management.