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ISO 13485:2016 – International Medical Device Quality Management System (QMS) Standard

NSF International
Training overview
2 hours
399.99 USD
English
Next start date: Inquire for more information - Online

Course description

ISO 13485:2016 – International Medical Device Quality Management System (QMS) Standard

This course provides in-depth instruction and expert clarification of ISO 13485:2016, the standard which serves as a basis for many medical device QMS regulations around the globe. This course covers the goals of the standard and provides in-depth instruction regarding Clause 4-QMS, Clause 5-Management Responsibility, Clause 6-Resource Management, Clause 7-Product Realization and Clause 8-Measurement Analysis and Improvement.

Training Content

Objectives

By the end of this course you should be able to:

  • Define the primary purpose of ISO 13485:2016
  • Identify the general and documentation requirements of a QMS as outlined in Clause 4
  • Recognize the responsibilities of management within a QMS as outlined in Clause 5
  • Identify the resources needed to implement and maintain an effective QMS; and meet regulatory and customer requirements as outlined in Clause 6
  • Recognize the requirements for planning and developing the processes needed for product realization as outlined in Clause 7
  • Identify requirements for planning and implementing monitoring, measuring, analysis and improvement processes as outlined in Clause 8

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Certification / Credits

Certificate

By completing/passing this course, you will attain the certificate Medical Device Certificate

About supplier

NSF International

NSF International

NSF Health Sciences partners with life science companies, big and small, to provide highly customized end-to-end services throughout the product lifecycle. From early development to commercial manufacture and distribution, our expert services will assist you to: Ensure regulatory compliance Implement...


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Reviews

Karla
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Very well organized and delivery was excellent!
Karla Palermo
(4)
Very well organized and delivery was excellent!
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ISO 13485:2016 – International Medical Device Quality Management System (QMS) Standard
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