Cybersecurity in MedTech: Surviving Digital Darkness and Meeting FDA & EU Demands

Medical Device Global Market Access · Mar 7, 2026 · 3m

This episode explores the growing threat of 'digital darkness'—total network outages caused by cyberattacks—and its impact on the medical device industry. We delve into the heightened scrutiny from regulatory bodies like the FDA and under the EU MDR, focusing on new requirements for manufacturers to prove their devices can function safely and effectively offline. We discuss key strategies for building cybersecurity resilience, from design and risk assessment to post-market surveillance. Key Questions - What is "digital darkness" and why is it a top concern for hospitals? - How are the FDA and…