ISO 13485 Training Course
This course equips healthcare professionals with essential skills for ISO 13485 compliance in medical device management, focusing on lifecycle control, risk management, CAPA processes, documentation, and audit preparation to ensure safety and efficiency.

from 4 to 360h flexible workload
valid certificate in your country
What will I learn?
The ISO 13485 Training Course provides practical skills to manage medical devices throughout their full lifecycle, from receiving and storage to use, reprocessing, maintenance, and disposal. Learn to apply ISO 13485 and ISO 14971, conduct effective CAPA and incident investigations, design clear forms and SOPs, prepare for audits, and develop a simple, sustainable implementation plan that enhances safety, compliance, and daily workflows.
Elevify advantages
Develop skills
- Master ISO 13485 basics: apply key clauses to daily hospital workflows.
- Control device lifecycle: standardize receiving, use, reprocessing, and disposal.
- Implement risk and CAPA: investigate incidents and prevent repeat failures.
- Build audit-ready records: design simple forms, logs, and traceable documentation.
- Train clinical teams: turn regulatory rules 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 are saying
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