Medical Device Compliance MasterTrack: ISO 13485, ISO 14971, IEC 62304, IEC 60601-1, MDR/IVDR, QSR Fundamentals Training by Tonex
Modern devices reach markets faster when quality systems, risk controls, and safety evidence are designed in from day one. This program brings together the cornerstone standards that regulators and auditors expect to see baked into your lifecycle. Because software is now central to many devices, we connect engineering practice with documentation that stands up to scrutiny.
Security is safety’s new partner—threats against connected devices can become clinical hazards. You will map cybersecurity requirements into risk management files, software lifecycle work products, and postmarket surveillance. The result is a pragmatic blueprint for compliant, secure, and audit-ready development.
Learning Objectives
- Translate ISO 13485 requirements into pragmatic QMS procedures and records
- Build end-to-end risk management aligned with ISO 14971 and clinical use
- Plan and generate IEC 62304 software lifecycle work products with traceability
- Demonstrate electrical safety and essential performance evidence under IEC 60601-1
- Structure MDR/IVDR technical documentation and PMS/PMCF strategies that satisfy NB review
- Align FDA QSR fundamentals with global expectations and prepare for inspections
- Integrate cybersecurity into safety risk management, vulnerability handling, and postmarket controls
Audience
- Regulatory Affairs Specialists
- Quality Managers and Auditors
- Systems and Software Engineers
- Clinical and Risk Managers
- Product Owners and Compliance Leads
- Cybersecurity Professionals
Course Modules
Module 1 – ISO 13485 Quality Management Essentials
- Scope, exclusions, and QMS architecture
- Document control and record management
- Design and development planning
- Purchasing controls and supplier oversight
- Production, release, and acceptance activities
- Internal audits, CAPA, and management review
Module 2 – ISO 14971 Risk Management Mastery
- Intended use, characteristics, and hazards
- Hazardous situations and harm estimation
- Risk control options and verification
- Benefit-risk analysis and residual risk
- Risk management plan, report, and file
- Postmarket feedback and risk updates
Module 3 – IEC 62304 Software Lifecycle Compliance
- Software safety classification and scoping
- Requirements, architecture, and detailed design
- Unit, integration, and system verification
- Problem resolution, anomalies, and traceability
- SOUP/OTS evaluation and supplier evidence
- Maintenance, change control, and documentation
Module 4 – IEC 60601-1 Safety and Performance
- Essential performance and risk linkage
- Electrical, mechanical, and thermal hazards
- Protection against electric shock and fire
- Usability interface with IEC 62366 alignment
- EMC references and collateral standards overview
- Test plans, reports, and compliance strategy
Module 5 – EU MDR and IVDR Compliance
- Device classification and conformity routes
- GSPR mapping and clinical evidence strategy
- Technical file and design dossier structure
- UDI, EUDAMED, and vigilance reporting
- PMS, PMCF, and periodic safety updates
- Notified Body audits and remediation playbook
Module 6 – FDA QSR Fundamentals and QMSR
- Device classification, submissions, and pathways
- Design controls and DHF/DHR/DMR structure
- Production controls, process validation, sterilization
- Complaint handling and medical device reporting
- Supplier controls and purchasing data integrity
- Inspection readiness, metrics, and continuous improvement
Ready to turn standards into competitive advantage and ship audit-ready devices with confidence? Enroll in the Medical Device Compliance MasterTrack by Tonex to align teams, accelerate approvals, and embed quality, safety, and cybersecurity into every release.