Medical Devices Quality Management System – ISO 13485:2016
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Medical Devices Quality Management System – ISO 13485:2016
$44.99
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Medical Devices Quality Management System - ISO 13485:2016
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$15.00 in stock
Udemy.com
as of September 22, 2025 1:08 am
Awareness and Application for the requirements of ISO 13485:2016 for Medical Device Development and QMS.
Created by:
Stendard Academy
The Stendard Academy
The Stendard Academy
Rating:4.26 (911reviews)
2279students enrolled
What Will I Learn?
- How ISO 13485 requirements apply to medical device companies
- Requirements of the ISO 13485:2016 standard
- The importance of implementing a Quality Management System per ISO 13485:2016
Requirements
- No specific prior knowledge is required
- Familiarity with quality management systems is helpful
- A general understanding of medical device life-cycle is useful
- Owning the ISO 13485:2016 standard is optional but recommended
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
- Quality managers
- Risk managers
- Medical device practitioners interested in the ISO 13485 framework
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