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.

from 4 to 360h flexible workload
certificate valid 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 will learn essential clauses, supplier management, validation processes, cleaning and sterilisation methods, and traceability for reusable instruments. Develop abilities in conducting gap analyses, implementing in stages, performing internal audits, handling CAPA, monitoring KPIs, and conducting management reviews to achieve and maintain certification readiness confidently.
Elevify advantages
Develop skills
- ISO 13485 fundamentals: understand the clauses, connections to FDA and EU regulations, and what auditors expect quickly.
- Supplier and production management: implement efficient, compliant buying and supervision practices.
- Performing gap analysis: assess existing operations, identify risks, and outline corrective actions.
- CAPA and internal auditing: examine problems, conduct audits, and confirm outcomes.
- Planning the QMS pathway: stage the rollout, 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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