About this webinar
What to expect.
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.
