EU MDR Cybersecurity Workshop by Tonex
Navigate the intersection of medical device regulation and secure-by-design engineering with a focused program built for teams moving products into the EU market. You’ll translate complex MDR clauses and MDCG guidance into practical development and post-market routines that actually fit engineering and quality workflows. The course ties regulatory expectations to lifecycle controls, verification evidence, and release decisions. Cybersecurity impact is addressed throughout: you’ll map threat modeling, SBOM governance, and secure update channels directly to MDR safety and performance requirements. You also learn how coordinated vulnerability disclosure and PSURs strengthen cybersecurity posture and protect patients and manufacturers alike.
Learning Objectives
- Translate EU MDR cybersecurity expectations into concrete engineering and quality tasks
- Build traceable evidence from requirements through verification and risk files
- Operationalize SBOM, vulnerability handling, and patch delivery in PMS/PMPF
- Align supplier controls, cloud/services, and UDI/EUDAMED data with MDR artifacts
- Improve audit readiness with objective metrics and living documentation
- Strengthen resilience with lifecycle threat modeling, secure updates, and coordinated disclosures; includes explicit focus on cybersecurity requirements
Audience
- Product Managers and Owners
- Systems and Software Engineers
- Quality and Regulatory Affairs Specialists
- Clinical and Risk Management Leads
- Security Architects and DevSecOps Engineers
- Cybersecurity Professionals
Module 1 – MDR Cyber Basics
- MDR scope and terminology
- General safety and performance
- Software as a medical device
- Cybersecurity risk integration
- MDCG guidance overview
- Notified body expectations
Module 2 – Risk & Threats
- ISO 14971 alignment
- Threat modeling methods
- Hazard vs. cyber events
- Risk control measures
- Residual risk rationale
- Evidence traceability
Module 3 – Secure Design
- Secure architecture patterns
- Identity and authentication
- Data protection in transit
- Secure update mechanisms
- Logging and monitoring
- Safety–security co-engineering
Module 4 – SBOM & Suppliers
- SBOM structure and policy
- Open source governance
- Third-party component risk
- Supplier qualification controls
- Vulnerability intake triage
- Remediation and patch cadence
Module 5 – Verification Evidence
- Security test planning
- Static/dynamic analysis use
- Penetration and fuzz testing
- Safety–security test links
- Objective evidence packaging
- Release gate criteria
Module 6 – PMS & PMPF
- Post-market surveillance setup
- PSURs and vigilance data
- Coordinated disclosure flow
- Incident response playbooks
- EUDAMED reporting touchpoints
- Continuous improvement loops
Ready to turn MDR cybersecurity requirements into confident, auditable practice? Contact Tonex to schedule this workshop for your team and accelerate compliant, secure product delivery.