ISO 13485 Training Course
This course provides comprehensive training on ISO 13485 standards for medical device management in healthcare settings, focusing on lifecycle processes, risk management, compliance, and audit preparation to ensure safety and efficiency.

4 to 360 hours of flexible workload
certificate valid in your country
What Will I Learn?
The ISO 13485 Training Course equips you with practical skills to manage medical devices throughout their entire lifecycle, from receipt and storage to usage, reprocessing, maintenance, and disposal. You will learn to apply ISO 13485 and ISO 14971, conduct effective CAPA and incident investigations, create clear forms and SOPs, prepare for audits, and develop a straightforward, sustainable implementation plan that enhances safety, compliance, and daily operations.
Elevify Advantages
Develop Skills
- Master the fundamentals of ISO 13485: apply key clauses to everyday hospital workflows.
- Manage the device lifecycle: standardise receiving, usage, reprocessing, and disposal.
- Execute risk management and CAPA: investigate incidents and prevent recurring failures.
- Create audit-ready records: design simple forms, logs, and traceable documentation.
- Train clinical teams: convert regulatory requirements into clear SOPs and bedside checklists.
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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