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ISO 13485:2016 Medical Device Quality Management System
- Overview
- On-Site Training
- Who Should Attend?
- Trainer Profile
NSF International teaches a variety of courses on ISO 13485:2016, Medical devices — Quality management systems. Our ISO 13485:2016 medical devices training focuses on the international standard that defines quality management system requirements for organizations that are or may become involved in one or more stages of the medical device product lifecycle. This includes design and development, production, storage and distribution, and installation or servicing of a medical device, as well as design and development or provision of associated activities such as technical support. ISO 13485:2016 can also be used by suppliers or external parties that provide product and quality management system-related services to such organizations.
On-Site Training
This one-day medical devices training course helps you better understand the requirements of ISO 13485:2016. You will learn:
- To understand the design specifications for the 2016 version of ISO 13485
- The difference between ISO 13485:2003 and ISO 13485:2016
- To comprehend the intent and meaning of all clauses of ISO 13485:2016
- To recognize the interrelationship and linkages between the clauses and requirements
Who Should Attend?
This ISO 13485:2016 training course is vital for any medical device quality professional (including quality directors, managers, engineers and auditors) responsible for implementing a quality management system in accordance with ISO 13485:2016.
Trainer Profile
NSF's courses are taught by experts who have years of experience in medical device quality standards and regulatory requirements. Our trainers are committed to creating a learning environment that is highly interactive and based on real scenarios to help you apply practices and improve behaviors within your workplace. Learn more about our trainer for this ISO 13485:2016 training course:
Upcoming Courses & Webinars
In ISO 13485:2016 Medical Device Quality Management System-
Quality Management Systems Lead Auditor Training, Incorporating ISO 13485:2016 and MDSAP Requirement
- Monday, March 11, 2019
- 8:30am - 12:00pm Eastern Time
- Reston, Virginia, United States
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Internal Auditor Training, Incorporating EU MDR and MDSAP Requirements
- Tuesday, March 26, 2019
- 9:00am - 5:00pm GMT
- London, England, United Kingdom
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European Medical Device Regulation (EU MDR)- Understanding and Implementing the Requirements
- Wednesday, May 1, 2019
- 9:00am - 5:00pm Eastern Time
- Reston, Virginia, United States
-
Quality Management Systems Lead Auditor Training, Incorporating ISO 13485:2016 and MDSAP Requirement
- Monday, May 13, 2019
- 8:30am - 12:00pm Eastern Time
- London, England, United Kingdom