Official websites use .gov
A .gov website belongs to an official government organization in the United States.
Secure .gov websites use HTTPS
A lock ( ) or https:// means you’ve safely connected to the .gov website. Share sensitive information only on official, secure websites.
Introduction to IEC 62304 (Medical Device Software)
Learn the fundamentals of medical device software safety with the "Introduction to IEC 62304 (Medical Device Software)" course. Understand software lifecycle processes, regulatory compliance, and risk management for medical applications.
Provider Information
Tonex, Inc.
6275 W. Plano Parkway, Suite 500
Plano, TX 75093
Course Overview
None
Learning Objectives
- Understand the requirements of IEC 62304.
- Apply the lifecycle processes defined in IEC 62304.
- Understand the documentation requirements of IEC 62304.
- Perform risk management according to IEC 62304.
- Understand the verification and validation requirements of IEC 62304.
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.