AI-enabled devices and device cybersecurity.

The next two areas of work: the fastest-moving requirements in medical devices in 2026.

AI in medical devices

ISO/TS 24971-2:2026: ISO 14971 applied to machine learning (June 2026)
IEC PAS 63621:2026: data management for AI-enabled devices (March 2026)
EU AI Act: medical-device dates moved to Aug 2028 / Dec 2030
FDA: AI lifecycle guidance still in draft; PCCP guidance final
South Korea: Digital Medical Products Act fully in force Jan 24, 2026

Device cybersecurity

Security built into the device's software, meaning protection against someone getting into the device itself. This is different from IT or network security.

FDA premarket cybersecurity expectations
IEC 81001-5-1 health software security lifecycle
EU MDR cybersecurity guidance

Pending These services are in development. Join the list to hear when the AI and cybersecurity checklists are ready.