ISO 13485 Course
This course equips participants with essential knowledge and practical skills to implement and maintain an ISO 13485-compliant Quality Management System (QMS) 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 guide to establish and enhance a compliant quality management system for medical devices. You'll learn about key clauses, supplier controls, validation, cleaning and sterilisation, and traceability for reusable instruments. Develop skills in gap analysis, phased implementation, internal audits, CAPA, KPIs, and management review to achieve and maintain certification readiness confidently.
Elevify advantages
Develop skills
- ISO 13485 essentials: understand clauses, FDA/EU connections, and audit requirements quickly.
- Supplier and production control: implement lean, compliant purchasing and oversight.
- Gap analysis execution: assess current practices, identify risks, and plan corrections.
- CAPA and internal audit: investigate issues, conduct audits, and confirm outcomes.
- QMS roadmap planning: stage implementation, allocate resources, and attain 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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