ISO 13485 Course
This course equips professionals with the knowledge and tools 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
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 will learn essential clauses, supplier management, validation processes, cleaning and sterilisation methods, and traceability for reusable instruments. Develop expertise in gap analysis, step-by-step implementation, internal audits, corrective and preventive actions, key performance indicators, and management reviews to achieve and maintain certification readiness confidently.
Elevify advantages
Develop skills
- ISO 13485 fundamentals: understand clauses, FDA/EU connections, and audit requirements quickly.
- Supplier and production oversight: implement efficient, compliant procurement and monitoring.
- Conducting gap analysis: assess existing practices, identify risks, and develop improvement plans.
- CAPA and internal auditing: probe problems, perform audits, and confirm outcomes.
- QMS implementation strategy: stage rollout, coordinate 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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