Cybersecurity is no longer a feature—it’s a fundamental aspect of safety, effectiveness, and patient trust. SRM must be integrated from design through decommissioning.
About this Whitepaper
As medical devices become increasingly digital, they face growing exposure to cybersecurity risks—posing potential threats to patient safety and regulatory compliance.
This white paper offers a comprehensive, practical guide to Security Risk Management (SRM) throughout the Total Product Lifecycle (TPLC), covering:
- Integration of cybersecurity in compliance with EU MDR 2017/745 and IVDR 2017/746
- Alignment with FDA and IMDRF cybersecurity expectations
- Use of threat modelling (STRIDE) and SBOMs for risk analysis
- Security V&V activities including penetration testing and vulnerability scanning
- Postmarket risk management and coordinated vulnerability disclosure
Whether you’re preparing a technical file, improving postmarket surveillance, or building secure-by-design software, this guide helps ensure your devices meet state-of-the-art standards like IEC 81001-5-1 and stay compliant with international regulations.
Who Should Read This?
Medical Device Regulatory & QA Professionals
Product Development & Cybersecurity Teams
Design Engineers & Risk Managers
EU MDR / IVDR Compliance Officers
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