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Certified Medical Safety Software Engineer (CMSE)

Gain specialized knowledge in medical software safety with the "Certified Medical Safety Software Engineer (CMSE)" course. Learn how to develop, validate, and certify software for medical devices while ensuring compliance with regulatory standards.

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 specific requirements for medical safety software.
  • Apply IEC 62304 standards in medical device software development.
  • Perform risk management and hazard analysis for medical software.
  • Understand FDA regulations and guidelines for medical software.
  • Develop and validate medical safety software.

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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