MDR GSPR 17: Cybersecurity Requirements Fundamentals Training by Tonex
Regulatory clarity is power. This course demystifies how MDR Annex I, GSPR 17 translates into practical, auditable cybersecurity expectations for medical devices and software. You will learn where safety and security meet, how to evidence conformity, and how to avoid common pitfalls that stall approvals. Cybersecurity is treated as a core safety risk driver across design, production, and post-market phases. You will translate threat scenarios into risk controls that Notified Bodies recognize, ensuring clinical performance is not jeopardized by security controls. The result is a confident, compliant pathway from design inputs to technical documentation and submission.
Learning Objectives
- Interpret MDR Annex I, GSPR 17 requirements into verifiable design and risk artifacts
- Map security risks to safety harms and essential performance impacts
- Build a conformity strategy that aligns with ISO 14971, IEC 81001-5-1, and IEC TR 60601-4-5
- Prepare evidence Notified Bodies expect across TD, QMS, and post-market files
- Integrate lifecycle threat management, SBOM, updates, and vulnerability handling
- Write one clear requirement about cybersecurity linking controls to safety and performance
Audience
- Regulatory Affairs Specialists
- Quality and Compliance Managers
- Product and Systems Engineers
- Clinical and Risk Management Professionals
- Software and DevOps Engineers
- Cybersecurity Professionals
Course Modules
Module 1 – GSPR 17 Essentials
- Scope and definitions
- Annex I mapping
- In/Out of device scope
- Safety linkage rationale
- Lifecycle applicability
- Evidence expectations
Module 2 – Safety–Security Linkage
- Harm and hazard analysis
- Essential performance ties
- Risk control prioritization
- Residual risk rationale
- Usability–security balance
- Benefit–risk narrative
Module 3 – Technical Controls
- Secure design inputs
- Authentication and access
- Data protection methods
- Secure update pathways
- Logging and monitoring
- Interoperability safety
Module 4 – Proving Compliance
- Conformity strategy plan
- Traceability to controls
- Verification and testing
- Vulnerability management
- Supplier and SBOM files
- Notified Body questions
Module 5 – Post-Market Cycles
- PMS and PMCF links
- Vigilance and reporting
- Security incident flow
- Patching and releases
- Field action criteria
- Change impact checks
Module 6 – Dossier and Submission
- GSPR checklist table
- Technical documentation
- Risk and test summaries
- IFU and labeling notes
- Clinical–security tie-in
- Audit-ready structure
Ready to turn MDR GSPR 17 from a hurdle into a competitive advantage? Enroll now to build audit-ready documentation, align safety and cybersecurity, and present persuasive evidence to Notified Bodies with confidence.