ISO 13485 Course
This course equips participants with the knowledge and skills to implement and maintain an ISO 13485-compliant Quality Management System (QMS) for medical devices, covering key standards, processes, and certification strategies.

from 4 to 360h flexible workload
valid certificate in your country
What will I learn?
The ISO 13485 Course provides a practical guide to establish and enhance a quality management system for medical devices that meets compliance standards. You will explore essential clauses, supplier management, validation processes, cleaning and sterilization methods, and traceability for reusable instruments. Develop expertise in conducting gap analyses, implementing in phases, performing internal audits, applying CAPA, tracking KPIs, and conducting management reviews to achieve and maintain certification readiness effectively.
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 supervision.
- Gap analysis execution: assess current practices, identify risks, and develop correction plans.
- CAPA and internal audit: examine problems, conduct audits, and confirm outcomes.
- QMS roadmap planning: stage implementation, coordinate resources, and attain certification.
Suggested summary
Before starting, you can change the chapters and 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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