ISO 13485 Training – Master Quality Management for Medical Devices
What is ISO 13485 Training?
ISO 13485 Training helps organizations in the medical device industry understand and implement a Quality Management System (QMS) based on the ISO 13485:2016 international standard. This training ensures your team is equipped to meet regulatory requirements, manage risks, and produce safe, effective medical devices.
Whether you’re a manufacturer, supplier, quality manager, or regulatory professional, ISO 13485 training gives you the tools to improve product quality, achieve compliance, and prepare for certification.
✅ Why ISO 13485 Training Matters
🏥 Required for medical device manufacturers and suppliers
✅ Helps meet FDA, EU MDR, and other global regulations
🔍 Supports risk management and product safety
📈 Improves process control and customer confidence
🏆 Prepares your organization for ISO 13485 certification and audits
🎯 Our ISO 13485 Training Programs
We offer tailored training solutions to fit your business needs:
| Training Type | What You’ll Learn |
|---|---|
| Awareness Training | Basics of ISO 13485 and the importance of medical device quality systems |
| Implementation Training | How to develop and manage a compliant QMS in line with ISO 13485 |
| Internal Auditor Training | How to audit your processes for compliance and continuous improvement |
| Lead Auditor Training | For professionals who want to audit external suppliers or third parties |
| Customized Workshops | Personalized training for your team, product types, or country-specific regulations |
📘 Key Topics Covered
Overview of ISO 13485:2016 requirements
Risk-based approach and product lifecycle control
Document control, traceability, and validation
Regulatory compliance (FDA, MDR, MDSAP)
Internal audits, CAPA, and management review
Supplier management and post-market surveillance
👥 Who Should Attend?
Quality Managers and Engineers
Regulatory Affairs Professionals
Internal Auditors and Compliance Teams
Medical Device Designers and Manufacturers
R&D, Production, and Validation Teams
🧑🏫 Training Formats
💻 Online (Live or Self-Paced)
🏢 On-Site at Your Facility
🏫 Public Workshops
🎓 Certificate of Completion Provided
✅ Improve Quality. Ensure Compliance. Protect Patients.
Our ISO 13485 Training helps your business stay compliant, reduce risks, and improve product safety. Whether you’re seeking certification or strengthening your internal systems, this training provides the knowledge and tools to succeed in the medical device industry.
📞 Contact us today to register for ISO 13485 training or to schedule a custom session for your organization.