Medical devices are powered by open source software components. Your developers didn't write the code. You don't directly control it. But once it's in your device, you're responsible for its safety and compliance.
This guide walks through the seven critical steps to ensure medical device cybersecurity and regulatory compliance — from SBOM transparency through pre-market submission.
What you'll learn
- Full SBOM generation for accurate, complete transparency of your components
- Automated vulnerability detection to identify and remediate risks early
- License compliance monitoring to reduce legal and operational exposure
- Continuous SDLC monitoring for secure-by-design development and pre-market submissions
Regulations the guide helps you navigate
- US FDA 524B (FD&C Act, 2023) — SBOM, vulnerability management, and patching obligations
- US FDA Cybersecurity Premarket Guidance (2023) — secure design, SBOM submission, lifecycle security
- US FDA Postmarket Cybersecurity Guidance (2016) — ongoing monitoring and remediation for new and legacy devices
- EU MDR (2017/745) & IVDR (2017/746) — cybersecurity as part of safety and performance
- EU Cyber Resilience Act (CRA, 2025–2027) — mandates SBOMs, secure updates, and vulnerability handling for "products with digital elements"
- GDPR (2016/679) — patient data protection and privacy for connected devices
- ISO 14971 — risk management for medical devices, including software security risks
- IMDRF Cybersecurity Guidance (2020/2022) — baseline international reference for lifecycle cybersecurity