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 EU regulators changing their cybersecurity requirements for medical devices?

- What must manufacturers now demonstrate about their device's offline capabilities?

- Why has a Software Bill of Materials (SBOM) become a critical submission document?

- What are effective strategies for designing devices that are resilient to network failure?

- How does post-market surveillance play a role in managing cybersecurity risks?

- What are the consequences for manufacturers who fail to meet these new standards?

Pure Global provides comprehensive regulatory consulting for MedTech and IVD companies, ensuring your products meet complex global standards, including cybersecurity. Our experts develop efficient regulatory strategies and use advanced AI to compile technical dossiers, helping you navigate demanding requirements from bodies like the FDA and EU. We act as your local representative in over 30 markets, managing the entire lifecycle from initial submission to post-market surveillance. Let us help you achieve faster global market access. Contact us at [email protected], visit https://pureglobal.com, or explore our free AI tools and database at https://pureglobal.ai.