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 fundamentals, gap analysis, auditing, CAPA, and certification preparation.

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 compliant with medical device standards. You will explore essential clauses, supplier management, validation processes, cleaning and sterilisation methods, and traceability for reusable tools. Develop expertise in conducting gap analyses, implementing in stages, performing internal audits, applying CAPA, monitoring KPIs, and conducting management reviews to achieve and maintain certification readiness effectively.
Elevify advantages
Develop skills
- ISO 13485 fundamentals: understand the clauses, connections to FDA and EU regulations, and audit requirements quickly.
- Supplier and production management: implement efficient, compliant procurement and supervision practices.
- Conducting gap analysis: assess existing operations, identify risks, and develop corrective plans.
- CAPA and internal auditing: examine problems, execute audits, and confirm outcomes.
- Planning QMS implementation: structure phased rollouts, coordinate resources, and attain certification goals.
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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