ISO 13485 Training Course
This course provides comprehensive training on ISO 13485 standards for medical device management in healthcare settings, focusing on compliance, risk management, and operational efficiency.

from 4 to 360h flexible workload
valid certificate in your country
What will I learn?
The ISO 13485 Training Course equips you with practical skills to handle medical devices throughout their entire lifecycle, from receiving and storage to usage, reprocessing, maintenance, and disposal. You will learn to implement ISO 13485 and ISO 14971, conduct effective CAPA and incident investigations, create straightforward forms and SOPs, get ready for audits, and develop a simple, lasting implementation plan that boosts safety, compliance, and everyday operations.
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 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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