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Overview of ISO 13485:2016 - Medical Devices Quality Management Systems Training

Overview of ISO 13485:2016 - Medical Devices Quality Management Systems Training: Understand the key updates and requirements of ISO 13485:2016 for quality assurance in medical devices.

Course Overview

Overall Proficiency Level
2 - Intermediate
Course Catalog Number
T101
Course Prerequisites

None

Training Purpose
Functional Development
Management Development
Specific Audience
All
Delivery Method
Online, Self-Paced
  • Online, Self-Paced

Learning Objectives

  • Understand the structure and requirements of ISO 13485:2016.
  • Learn to implement and maintain a compliant QMS.
  • Identify key changes in the 2016 revision.
  • Ensure effective internal and external audit readiness.
  • Improve organizational quality and compliance standards.

Framework Connections

The materials within this course focus on the NICE Framework Task, Knowledge, and Skill statements identified within the indicated NICE Framework component(s):

Feedback

If you would like to provide feedback on this course, please e-mail the NICCS team at NICCS@mail.cisa.dhs.gov. Please keep in mind that NICCS does not own this course or accept payment for course entry. If you have questions related to the details of this course, such as cost, prerequisites, how to register, etc., please contact the course training provider directly. You can find course training provider contact information by following the link that says “Visit course page for more information...” on this page.

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