Three shifts in the last 18 months moved medical device cybersecurity from a CISO concern to a C-suite one. FDA cyber deficiency letters are up 700%. QMSR inspections went live in February. The EU Cyber Resilience Act's mandatory vulnerability reporting deadline hits September 11, 2026.

This 45-minute briefing gives device manufacturer leadership a clear view of the new regulatory environment — and a 90-day action plan.

You'll learn:

• Why hospital procurement is now the gatekeeper, and how 4.9% median margins changed the buyer conversation
• What FDA enforcement actually looks like under Section 524B, including the January 2026 Beta Bionics warning letter
• What QMSR inspectors are asking for based on the first 100 inspections under CP 7382.850
• Why the EU CRA likely touches you, even if your regulated device is excluded
• Three concrete moves to make in the next 90 days — CRA scope assessment, premarket gap review, and postmarket vulnerability pipeline

Who should attend

CEOs, COOs, CTOs, Chief Quality Officers, and VPs of Regulatory Affairs or Product Security at medical device manufacturers selling into US hospitals or EU markets.

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