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Course Details

Implementing ISO 13485:2016

Course Area

Medical Devices

Course Duration

2 Days

Continuing Education Units

1.6

Course Fee

USD $1195.00

Early Bird Price*

USD $1095.00

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Course Details

You'll be introduced to the concepts needed to understand, develop and implement a Quality Management System (QMS). This course provides the knowledge and process steps to enable the effective implementation of a QMS that is in line with the requirements for ISO 13485:2016 certification.

How will I benefit?

This course will help you:

  • Understand how to implement a QMS as required by medical device directives
  • Plan the implementation of ISO 13485:2016 within your organization
  • Take the first steps towards ISO 13485:2016 certification
  • Identify how you can better meet regulatory requirements
  • Find ways to increase efficiency and add value through quality management
  • Monitor supply chains to achieve continuous improvement

What will I learn?

On completion, you should gain the knowledge and skills to:

  • Define a quality management system
  • Identify the steps for defining, planning, organizing and scheduling necessary activities
  • Implement an effective quality management system
  • Conduct a base line review of an organization's current position with regard to ISO 13485:2016

Who should attend?

Anyone involved in defining, planning, or implementing an ISO 13485:2016 QMS, as well as management representatives and implementation team members.

Live Online Classes

Certified, convenient, and interactive, with no travel costs.

Private Class

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Questions?

For questions regarding any of our courses, contact us or call 1.800.217.1390.

Questions?

For questions regarding any of our courses, contact us or call 800.217.1390 (USA) 800.862.6752 (Canada)

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