Postmarket Surveillance (PMS) & Cyber Vigilance Fundamentals Training by Tonex
Regulatory expectations on postmarket surveillance have expanded, and cyber vigilance is now a decisive element of MDR readiness. This course clarifies how PMS processes intersect with vulnerability monitoring, incident triage, and risk communication across the device lifecycle. You’ll learn to translate MDR Annex III and Article 83–92 requirements into pragmatic surveillance plans and produce defensible evidence for audits. Cybersecurity impact is emphasized throughout—participants practice mapping threats to clinical risk and documenting controls that withstand scrutiny. You will connect SBOM intelligence, CERT and ISAC alerts, and manufacturer responsibilities to achieve a continuously improving PMS and vigilance system.
Learning Objectives
- Build a compliant PMS plan aligned to MDR requirements
- Operationalize cyber monitoring obligations across suppliers and devices
- Execute cyber incident FSCA decision-making and documentation
- Design actionable cyber trend reporting that informs risk controls
- Leverage CERT, ISACs, and SBOM insights for timely mitigation
- Strengthen device safety and cybersecurity through integrated vigilance
Audience
- Regulatory Affairs Specialists
- Quality and Compliance Managers
- Product Security Engineers
- Clinical and Risk Management Leads
- Cybersecurity Professionals
- Postmarket Surveillance and Vigilance Teams
Program Modules
Module 1 – MDR PMS Basics
- PMS plan elements
- Annex III evidence
- PSUR vs PMS report
- Roles and interfaces
- Supplier oversight
- Audit-readiness files
Module 2 – Cyber Monitoring
- Threat intel sources
- Vulnerability intake flow
- Asset and SBOM mapping
- Exploitability screening
- Triage and prioritization
- Escalation criteria
Module 3 – Cyber Incident FSCA
- Vigilance thresholds
- FSCA vs field notice
- EUDAMED submissions
- CAPA linkages
- Patient/clinician comms
- Evidence retention
Module 4 – Trend Reporting
- Signal detection rules
- Metrics and KPIs
- Time-series baselining
- Near-miss aggregation
- Risk re-evaluation
- Management review packs
Module 5 – CERT and ISACs
- Membership and tooling
- Alert validation steps
- Sector coordination
- Intel-to-control mapping
- Coordinated disclosure
- Post-incident learning
Module 6 – SBOM Intelligence
- Format and fidelity
- Version drift control
- Vulnerability correlation
- Supplier attestations
- Patch and workaround
- Residual risk record
Elevate your MDR compliance and resilience in one focused program. Enroll your team in Tonex’s Postmarket Surveillance & Cyber Vigilance Fundamentals to operationalize PMS, strengthen cybersecurity evidence, and pass audits with confidence.