ISO 13485 Training Course
This course equips healthcare professionals with essential skills to implement ISO 13485 standards for medical device management, ensuring compliance, safety, and efficient workflows in clinical settings.

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 workload. Choose which chapter to start with. Add or remove chapters. Increase or decrease the course workloadWhat our students say
FAQs
Who is Elevify? How does it work?
Do the courses have certificates?
Are the courses free?
What is the course workload?
What are the courses like?
How do the courses work?
What is the duration of the courses?
What is the cost or price of the courses?
What is an EAD or online course and how does it work?
PDF Course