Secure-by-Design: Using Hardware and Software Protection for FDA Compliance
Thursday, June 20, 2024 (1:00 PM - 2:00 PM) (EDT)
Description
The third in our series on medical device cybersecurity, this webinar explores the “secure-by-design” approach to medical device software development. The FDA considers this approach integral to a design process compliant with quality system regulations 21 CFR 820.30(c) and (d) and is highlighted in their cybersecurity pre-market guidance.
The FDA expects device makers to address multiple control categories in their pre-market submissions. Whilst in principle you could address all from scratch, a more practical approach is to leverage hardware capabilities and third-party security solutions to ensure compliance and enhance the overall trust and reliability of your products.
During this important session, we will:
- Outline which security measures should be considered for compliance
- Identify technical solutions available on various hardware platforms
- Summarize hardware protection methods (e.g. Secure Boot, HSMs and TPMs) you should consider when building in security
- Review security software such as Trusted Execution Environments for secure storage of keys and data, and Intrusion Detection Protection Systems to monitor for threats
Join us to learn more about how these technologies can make your devices compliant with the new FDA cybersecurity guidelines.