Requirements Engineering for Medical Devices Essentials Training by Tonex
Designed for regulated health-tech work, this program builds the discipline to capture, analyze, validate, and maintain requirements across the full device lifecycle. You’ll master end-to-end traceability from user need to design output and verification evidence while navigating ISO 13485, ISO 14971, IEC 62304, and FDA expectations.
Cybersecurity is treated as a first-class requirement set, with threat-informed controls woven into design inputs, risk files, and verification plans. You will learn to model security requirements, manage SBOM dependencies, and document secure configurations that withstand audits. The result is safer products, faster compliance readiness, and a resilient requirements baseline.
Learning Objectives
- Elicit stakeholder and clinical user needs with measurable acceptance criteria
- Build and maintain bidirectional traceability from needs to design outputs and tests
- Write verifiable, unambiguous, risk-aware software and system requirements
- Operationalize ISO 14971 risk controls within requirements and change management
- Configure and govern DOORS/Polarion for medical device requirements at scale
- Plan verification and validation strategies aligned to regulatory submissions
- Integrate security-by-design; specify cybersecurity requirements and test evidence
Audience
- Requirements Engineers and Analysts
- Systems and Software Engineers
- Quality and Regulatory Affairs Professionals
- Product Owners and Project Managers
- Clinical Engineers and Risk Managers
- Verification and Validation Engineers
- Cybersecurity Professionals
Course Modules
Module 1 – Foundations of Med-Device Requirements
- Role of requirements in quality system
- Regulatory landscape and expectations
- User needs vs design inputs
- Good requirement language patterns
- Nonfunctional needs and constraints
- Bidirectional traceability principles
Module 2 – Elicitation and Stakeholder Analysis
- Voice of customer and clinician workflows
- Context of use and hazard identification
- Scenarios, personas, and misuse cases
- Translating needs to measurable criteria
- Managing conflicts and prioritization
- Change control during discovery
Module 3 – Risk-Driven Requirements Engineering
- ISO 14971 linkage to requirements
- Hazard, sequence, harm, and controls
- Security threat modeling basics (STRIDE)
- Safety-security co-engineering tradeoffs
- Risk acceptance and residual tracking
- Traceable risk control verification
Module 4 – Tools and Data Governance (DOORS/Polarion)
- Project structures and artifact types
- Templates, attributes, and baselines
- Linking needs, designs, and tests
- Reviews, workflows, and e-signatures
- SBOM and configuration trace links
- Metrics, dashboards, and audits
Module 5 – Verification, Validation, and Evidence
- Writing testable requirements
- Verification methods and planning
- Evidence packages for submissions
- Handling anomalies and deviations
- Requirements coverage analysis
- Defining acceptance and release criteria
Module 6 – End-to-End Traceability in Practice
- Building a trace matrix that lives
- Linking user needs to design outputs
- Managing software of unknown provenance
- Cybersecurity requirements and test proofs
- Post-market changes and re-verification
- Preparing for audits and inspections
Ready to standardize traceability, accelerate submissions, and embed cybersecurity into your requirements baseline? Enroll in the Requirements Engineering for Medical Devices Essentials Training by Tonex and equip your team to deliver compliant, secure, and patient-safe devices with confidence.