ISO 13485 Training Course
Gain expertise in ISO 13485 for healthcare environments through this comprehensive training. Master medical device lifecycle management, risk assessment using ISO 14971, CAPA processes, incident investigation, documentation design, SOP creation, audit preparation, and team training. Achieve improved patient safety, regulatory compliance with FDA and MDR, and streamlined daily workflows for sustainable clinical practices.

flexible workload of 4 to 360h
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, including receiving, storage, usage, 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 to enhance safety, compliance, and operational efficiency in healthcare settings.
Elevify advantages
Develop skills
- Master core ISO 13485 requirements and apply them effectively to hospital operations.
- Manage complete medical device lifecycle from receipt to safe disposal.
- Execute risk management and CAPA to investigate incidents and avoid recurrences.
- Develop audit-compliant records with simple forms, logs, and documentation.
- Train clinical staff using straightforward SOPs and practical 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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