ISO 13485 Training Course
Master ISO 13485 in healthcare settings. Gain skills in device lifecycle control, risk management, CAPA processes, documentation, and audit readiness. This equips clinical teams to boost patient safety, comply with FDA/MDR standards, and maintain sustainable daily practices that enhance workflows and regulatory adherence.

from 4 to 360h flexible workload
valid certificate in your country
What will I learn?
This ISO 13485 Training Course equips you with practical skills to manage medical devices throughout their lifecycle—from receiving and storage to use, reprocessing, maintenance, and disposal. You will learn to implement ISO 13485 and ISO 14971 standards, conduct effective CAPA and incident investigations, create clear forms and SOPs, prepare for audits, and develop a simple, sustainable plan that boosts safety, compliance, and efficiency in daily operations.
Elevify advantages
Develop skills
- Master ISO 13485 basics: apply key clauses to daily hospital workflows.
- Control device lifecycle: standardise 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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