ISO 13485 Training Course
This course provides comprehensive training on ISO 13485 standards for medical device management, focusing on lifecycle control, risk management, CAPA processes, documentation, and audit preparation to ensure compliance and safety in healthcare settings.

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 manage medical devices throughout their entire lifecycle, from receiving and storage to use, reprocessing, maintenance, and disposal. You will 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 the basics of ISO 13485 by applying key clauses to everyday hospital workflows.
- Control the medical device lifecycle by standardising receiving, use, reprocessing, and disposal.
- Implement risk management and CAPA by investigating incidents and preventing repeat failures.
- Build audit-ready records by designing simple forms, logs, and traceable documentation.
- Train clinical teams by turning 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
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