ISO 13485 Course
This course equips professionals with the knowledge and skills to implement and maintain an ISO 13485 compliant quality management system for medical devices, covering key standards, processes, and certification strategies.

4 to 360 hours flexible workload
valid certificate in your country
What will I learn?
The ISO 13485 Course provides a practical roadmap to build and improve a compliant quality management system for medical devices. Learn key clauses, supplier controls, validation, cleaning and sterilisation, and traceability for reusable instruments. Gain skills in gap analysis, phased implementation, internal audits, CAPA, KPIs, and management review so you can reach and sustain certification readiness with confidence.
Elevify advantages
Develop skills
- ISO 13485 essentials: grasp clauses, FDA/EU links, and audit expectations fast.
- Supplier and production control: apply lean, compliant purchasing and oversight.
- Gap analysis execution: map current practices, expose risks, and plan fixes.
- CAPA and internal audit: investigate issues, run audits, and verify results.
- QMS roadmap planning: phase implementation, align resources, and hit certification.
Suggested summary
Before starting, you can change the chapters and the workload. Choose which chapter to start with. Add or remove chapters. Increase or decrease the course workload.What our students say
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