Episode 3: Navigating the Regulatory Landscape of Medical Device Cybersecurity

What are the main categories of medical devices, and how do regulatory bodies govern them?

In this episode, Christian Espinosa and Trevor Slattery unpack the complex regulatory environment surrounding medical device cybersecurity. In discussing the key regulations, standards, and FDA guidelines that govern the industry, they explore how these regulations shape the design, development, and deployment of secure medical devices. Topics discussed and key points:

• Incorporating cybersecurity from the beginning of the medical device development process.
• The challenges of integrating cybersecurity into medical devices after they have been developed.
• The impact of the FDA’s new guidance on medical device cybersecurity and the increase in submission rejections.
• The different classifications of medical devices and their associated risks.
• How vulnerability can lead to more significant security risks.
• Real-world examples of medical device vulnerabilities.
• The role of regulations in improving the safety and security of medical devices.