ISO 13485 Course
This course equips participants with the knowledge and skills 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 quality management system compliant with medical device standards. You will learn essential clauses, supplier management, validation processes, cleaning and sterilisation methods, and traceability for reusable tools. Develop abilities in conducting gap analyses, implementing in stages, performing internal audits, handling CAPA, monitoring KPIs, and conducting management reviews to achieve and maintain certification readiness effectively.
Elevify advantages
Develop skills
- ISO 13485 fundamentals: understand clauses, connections to FDA/EU regulations, and audit requirements quickly.
- Supplier and production oversight: implement efficient, compliant procurement and monitoring.
- Performing gap analysis: assess existing practices, identify risks, and develop correction plans.
- CAPA and internal auditing: examine problems, conduct audits, and confirm outcomes.
- Planning QMS roadmap: stage the 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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