The Complete ISO 13485 QA Course for Medical Devices [2025]

Master ISO 13485 quality assurance standards for medical devices: system design, documentation, audits, and compliance
4.52 (33 reviews)
Udemy
platform
English
language
Industry
category
Natalia Raleva
instructor
The Complete ISO 13485 QA Course for Medical Devices [2025]
1 082
students
9 hours
content
Jun 2025
last update
$19.99
regular price

What you will learn

Understand the full structure, purpose, and scope of ISO 13485

Apply the key clauses including Quality Management, Resource Management, Product Realization, and Measurement & Improvement

Build and manage compliant documentation including quality policies, objectives, manuals, SOPs, and records

Conduct internal audits and management reviews that prepare your company for ISO certification

Align your quality system with ISO 13485, ensuring safety, traceability, and regulatory readiness

Create an audit-ready culture of quality, accountability, and continuous improvement

Course Gallery

The Complete ISO 13485 QA Course for Medical Devices [2025] – Screenshot 1
Screenshot 1 – The Complete ISO 13485 QA Course for Medical Devices [2025]
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Screenshot 2 – The Complete ISO 13485 QA Course for Medical Devices [2025]
The Complete ISO 13485 QA Course for Medical Devices [2025] – Screenshot 3
Screenshot 3 – The Complete ISO 13485 QA Course for Medical Devices [2025]
The Complete ISO 13485 QA Course for Medical Devices [2025] – Screenshot 4
Screenshot 4 – The Complete ISO 13485 QA Course for Medical Devices [2025]

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udemy ID
07/04/2025
course created date
10/04/2025
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