Introduction to Working in the Medical Device Industry Fundamentals Training by Tonex
Stepping into the medical device field demands a sharp grasp of lifecycle rigor, human safety, and disciplined engineering—without losing speed to market. This course orients new professionals to how ideas move from user needs to validated, compliant products through design controls, risk management, and quality systems thinking. Because today’s devices are increasingly connected, you will learn how cyber risk intersects with patient safety, reliability, and clinical outcomes. We translate cybersecurity into practical engineering and documentation choices. Expect clear guidance on regulatory expectations for security-by-design, vulnerability handling, and postmarket monitoring so your teams can prevent harm and sustain trust.
Learning Objectives:
- Explain the end-to-end medical device lifecycle and critical decision gates
- Apply FDA/ISO design control elements to requirements, verification, and validation
- Map ISO 14971 risk management to usability, software, and manufacturing controls
- Distinguish QMS documentation that is value-adding versus compliance-only
- Collaborate effectively across R&D, clinical, regulatory, and quality teams
- Integrate cybersecurity into safety risk analyses, threat modeling, and postmarket vigilance
Audience:
- New Medical Device Engineers
- Quality and Regulatory Associates
- Clinical/Scientific Affairs Staff
- Product and Program Managers
- Manufacturing and Process Engineers
- Cybersecurity Professionals
Course Modules:
Module 1 — Industry Landscape Basics
- Class I/II/III device taxonomy
- Stakeholders and value chain
- Intended use and indications
- SaMD and embedded software scope
- Clinical evaluation essentials
- Reimbursement and market access
Module 2 — Design Control Essentials
- User needs and design inputs
- Architectural decomposition practices
- Verification vs. validation clarity
- Design reviews and trace matrices
- DHF, DMR, and DHR linkages
- Change control and configuration
Module 3 — QMS and Documentation
- ISO 13485 process architecture
- SOPs, work instructions, records
- Supplier qualification and control
- Nonconformances and CAPA flow
- Document control and training
- Production and process controls
Module 4 — Risk and Safety Management
- ISO 14971 risk process steps
- Hazard analysis and harm mapping
- FMEA, FTA, and PHA alignment
- Usability engineering per IEC 62366
- Benefit-risk and residual risk
- Risk files maintenance strategy
Module 5 — Regulatory Pathways and Submissions
- FDA 510(k), De Novo, PMA overview
- CE Marking and EU MDR basics
- Standards utilization and declarations
- Clinical evidence and GCP alignment
- Technical file and STED structure
- Interactions with regulators best-practices
Module 6 — Cybersecurity and Postmarket
- Security-by-design requirements integration
- Threat modeling tied to safety risks
- SBOM, patching, and update strategy
- Vulnerability disclosure and PSURs
- Postmarket surveillance signal triage
- Field actions and recall readiness
Ready to accelerate your onboarding and contribute confidently to compliant, secure, and patient-centric devices? Enroll now with Tonex to gain practical templates, decision checklists, and expert guidance you can apply on day one.