ISO 13485 Course
This course equips professionals with essential knowledge and skills to implement and maintain an ISO 13485-compliant quality management system for medical devices, covering standards, processes, audits, 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 for medical devices that meets standards. You will learn about key clauses, managing suppliers, validation processes, cleaning and sterilisation, and tracking for reusable instruments. Develop abilities in gap analysis, step-by-step implementation, internal audits, corrective actions, performance indicators, and management reviews to achieve and maintain certification readiness confidently.
Elevify advantages
Develop skills
- ISO 13485 basics: understand clauses, connections to FDA/EU, and what audits expect quickly.
- Supplier and production management: use efficient, standard-compliant buying and supervision.
- Conducting gap analysis: assess current methods, identify risks, and outline solutions.
- CAPA and internal audits: examine problems, perform audits, and confirm outcomes.
- Planning QMS roadmap: implement in stages, 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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