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  4. Introduction to Medical Device Regulation (MDR) Compliance

Introduction to Medical Device Regulation (MDR) Compliance

Introduction to Medical Device Regulation (MDR) Compliance: A foundational course to navigate regulatory compliance under the MDR framework for 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 key principles of MDR compliance.
  • Learn the regulatory pathways for medical devices.
  • Develop skills in MDR documentation and submission.
  • Identify risks and implement regulatory strategies.
  • Ensure product safety and compliance with MDR.

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):

Competency Areas

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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