Medical Devices Quality Management System - ISO 13485:2016
- Offered byUDEMY
Medical Devices Quality Management System - ISO 13485:2016 at UDEMY Overview
Medical Devices Quality Management System - ISO 13485:2016
at UDEMY
Awareness and Application for the requirements of ISO 13485:2016 for Medical Device Development and QMS.
Duration | 2 hours |
Total fee | ₹389 |
Mode of learning | Online |
Official Website | Go to Website  |
Credential | Certificate |
Medical Devices Quality Management System - ISO 13485:2016 at UDEMY Highlights
Medical Devices Quality Management System - ISO 13485:2016
at UDEMY
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- Full lifetime access
- Certificate of completion
- 30-Day Money-Back Guarantee
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Medical Devices Quality Management System - ISO 13485:2016 at UDEMY Course details
Medical Devices Quality Management System - ISO 13485:2016
at UDEMY
Skills you will learn
Who should do this course?
- 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
What are the course deliverables?
- 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
More about this course
- This Course standard specifies requirements for the Medical Device Development and Quality Management System (QMS) that should be used by medical device-related companies.
- Having a proper QMS in place is essential for medical device-related companies. Global regulatory requirements emphasise this and make it mandatory for such standards to be adhered to by companies worldwide.
Medical Devices Quality Management System - ISO 13485:2016 at UDEMY Curriculum
Medical Devices Quality Management System - ISO 13485:2016
at UDEMY
Introduction-Getting started on the ISO 13485:2016
Introduction to ISO 13485:2016
Clauses-by-clause guidance for ISO 13485:2016
Clause 5: Management Responsibility + Clause 6: Resource Management
Clause 7: Product Realization
Preparation of documentation
Preparation of documentation
Implementation
Implementation
Verification of your implementation
Bonus Lecture
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Medical Devices Quality Management System - ISO 13485:2016
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