The rapid growth of connectivity in medical devices exposes them to significant cybersecurity risks. Incidents such as ransomware attacks that disrupted hospital operations, delayed patient care, and put sensitive patient data at risk prompted a key legislative milestone in this field is the Omnibus Act of 2023, empowering the FDA to strengthen cybersecurity requirements for medical devices. The FDA has followed up with guidance and a “refuse to accept” policy for devices with cybersecurity deficiencies.

Click the PDF below to view the slides presented to the ASQ Silicon Valley Section on the topic of Cybersecurity for Medical Devices.