ISO 13485 Training Course
This course provides comprehensive training on ISO 13485 standards for medical device management, focusing on lifecycle processes, risk management, CAPA, documentation, and audit preparation to ensure compliance and safety in healthcare settings.
from 4 to 360h flexible workload
certificate valid 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 receipt and storage to usage, reprocessing, maintenance, and disposal. You'll learn to implement ISO 13485 and ISO 14971, conduct effective CAPA and incident investigations, create straightforward forms and SOPs, prepare for audits, and develop a straightforward, sustainable implementation plan that enhances safety, compliance, and everyday workflows.
Elevify advantages
Develop skills
- Master the fundamentals of ISO 13485: apply essential clauses to routine hospital operations.
- Manage the device lifecycle: standardise receipt, usage, reprocessing, and disposal.
- Apply risk management and CAPA: probe incidents and avert recurring issues.
- Create audit-ready documentation: design uncomplicated forms, logs, and trackable records.
- Educate clinical staff: convert regulatory requirements into straightforward SOPs and point-of-care 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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