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.
IEC 62304 (Software Lifecycle for Medical Devices) Fundamentals
Understand the software lifecycle requirements for medical devices with "IEC 62304 (Software Lifecycle for Medical Devices) Fundamentals." Learn about compliance, risk management, and regulatory expectations for developing safe and effective medical software.
Course Overview
None
Learning Objectives
- Understand the purpose and scope of IEC 62304.
- Analyze the software lifecycle processes defined in IEC 62304.
- Evaluate the software safety classifications and their implications.
- Identify the documentation requirements for medical device software.
- Discuss the verification and validation activities required by 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.