ISO 13485: Quality Management Systems for Medical Devices Essentials Training by Tonex
Medical device teams face exacting regulatory demands and unforgiving launch windows. This program shows how to build, certify, and sustain an ISO 13485 quality management system that works in the real world—tight, lean, and audit-ready. You’ll connect design controls, risk management, and supplier quality to consistent product safety and effectiveness. Cybersecurity now intersects with quality and patient safety; we demonstrate how secure development and data integrity strengthen records, CAPA, and vigilance. You’ll also see how cyber risk in software and connected devices translates into concrete QMS evidence that notified bodies and regulators increasingly expect.
Learning Objectives
- Explain ISO 13485 purpose, scope, and principles
- Translate clauses into practical processes and records
- Build design controls with clear traceability
- Apply risk-based thinking across lifecycle stages
- Link ISO 14971 risk files to QMS evidence
- Establish supplier qualification and ongoing monitoring
- Validate manufacturing processes and equipment capabilit
Audience
- Quality managers and engineers
- Regulatory affairs professionals
- R&D and design engineers
- Manufacturing and operations leaders
- Clinical and post-market teams
- Cybersecurity Professionals
- Supplier quality and procurement
- Project and product managers
Course Modules
Module 1 – ISO 13485 Basics
- Scope and applicability
- Clause structure overview
- Process-based approach
- Risk-based thinking
- Quality objectives setting
- Certification roadmap
Module 2 – Design Controls
- Design planning gates
- User needs capture
- Design inputs clarity
- Design reviews cadence
- V&V strategy alignment
- Change control discipline
Module 3 – Risk Management
- ISO 14971 linkage
- Hazard identification methods
- Risk estimation criteria
- Risk control selection
- Residual risk evaluation
- PMS feedback loops
Module 4 – Production Quality
- Process validation rules
- Equipment qualification IQ/OQ/PQ
- Incoming inspection plans
- Nonconforming control flow
- In-process monitoring checks
- Release and labeling
Module 5 – Suppliers & Outsourcing
- Supplier qualification plans
- Quality agreements essentials
- Performance KPIs dashboards
- Audits and re-evaluation
- Escalation and containment
- Outsourced process control
Module 6 – Documents & Records
- Document hierarchy design
- Electronic records integrity
- Training and competence
- DMR/DHR completeness
- Change control workflows
- Record retention rules
Elevate compliance into competitive advantage and protect patients, products, and your brand. Enroll now in Tonex’s ISO 13485 Essentials to build a lean, audit-ready QMS that accelerates safe, effective medical devices to market.