ISO 13485 Course
This course equips participants with the knowledge and tools to implement and maintain an ISO 13485-compliant quality management system for medical devices, covering fundamentals, gap analysis, audits, 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 compliant quality management system for medical devices. You will learn essential clauses, supplier management, validation processes, cleaning and sterilization methods, and traceability for reusable instruments. Develop expertise in gap analysis, step-by-step implementation, internal audits, corrective and preventive actions (CAPA), key performance indicators (KPIs), and 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 what auditors expect quickly.
- Supplier and production management: implement lean and compliant purchasing strategies along with proper oversight.
- Conducting gap analysis: assess existing practices, identify risks, and develop action plans for improvements.
- CAPA and internal auditing: probe into problems, perform audits, and confirm corrective measures.
- Planning the QMS roadmap: structure phased rollout, 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 are saying
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