Webinar: When Cybersecurity Should Be Considered for MedTech Launches

Key takeaways

• Cybersecurity integration should begin at the earliest stages of medical device design and development.
• Proactive cybersecurity measures are crucial for meeting regulatory requirements, such as those outlined in FDA Section 524B and IEC 62304.
• Understanding and implementing risk management frameworks like ISO 14971 is key to identifying and mitigating cybersecurity vulnerabilities.
• The use of tools like SBOM/VEX can enhance transparency and facilitate vulnerability management throughout the device lifecycle.
• Preparing for regulatory submissions like eSTAR requires a robust cybersecurity profile.
• Adopting a secure product development framework (SPDF) is essential for building inherently secure medical devices.
• Early cybersecurity focus helps prevent costly post-market remediation and builds patient and provider trust.