ISO 13485 Training Course
Master ISO 13485 in healthcare settings. Learn device lifecycle control, risk management, CAPA, documentation, and audit readiness so your clinical teams improve patient safety, meet FDA/MDR expectations, and sustain compliant daily practice.

from 4 to 360h flexible workload
valid certificate in your country
What will I learn?
The ISO 13485 Training Course gives you practical skills to manage medical devices across their full lifecycle, from receiving and storage to use, reprocessing, maintenance, and disposal. Learn how to apply ISO 13485 and ISO 14971, run effective CAPA and incident investigations, design clear forms and SOPs, prepare for audits, and build a simple, sustainable implementation plan that improves 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 say
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