Internal audit on Medical Device QMS – ISO 13485:2016
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- The lowest price of Internal audit on Medical Device QMS - ISO 13485:2016 was obtained on October 2, 2025 4:19 pm.
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Internal audit on Medical Device QMS - ISO 13485:2016
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$14.00 in stock
Udemy.com
as of October 2, 2025 4:19 pm
Successfully conduct an internal audit based on requirements of ISO 13485:2016 for Medical Device Development and QMS
Created by:
Stendard Academy
The Stendard Academy
The Stendard Academy
Rating:4.44 (1061reviews)
2726students enrolled
What Will I Learn?
- Conducting an entire internal audit based on ISO 13485:2016 requirements
- General concepts and principles of auditing
- Establishing and preparing for the audit
- Performing the audit (How to conduct a mock audit based on compiled checklist?)
- Reporting the audit results
- Post-audit activities and CAPA planning
Requirements
- Owning the ISO 13485:2016 standard is optional but recommended
- Attending our "Medical Devices Quality Management System - ISO 13485:2016" course is optional, but recommended for beginners
- Familiarising with compiled audit checklist (included in this course resource
Target audience
- Medical device companies looking to set up their QMS and get ISO 13485:2016 certified
- Professionals tasked with overseeing a management system meeting ISO 13485 standards
- Professionals tasked with overseeing an internal audit based on ISO 13485 requirements
- Quality managers
- Risk managers
- Medical device practitioners interested in the ISO 13485 framework
- Anyone who wishes to be able to properly conduct a mock audit independently
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