Introduction to IEC 62304 (Medical Device Software) from Tonex, Inc.

Introduction to IEC 62304 (Medical Device Software)

Online, Self-Paced

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.

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

Design and Development

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

Work Roles

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.