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 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 oversight, validation processes, cleaning and sterilisation methods, and traceability for reusable instruments. Develop expertise in gap analysis, step-by-step implementation, internal audits, corrective actions, key performance indicators, and 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 oversight: implement efficient, compliant purchasing and monitoring practices.
- Conducting gap analysis: assess existing operations, identify risks, and outline corrective measures.
- CAPA and internal audits: probe into problems, perform audits, and confirm effective outcomes.
- Planning QMS roadmap: stage the rollout, coordinate resources, and secure certification success.
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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