IEC 62304 (Software Lifecycle for Medical Devices) Fundamentals from Tonex, Inc.

IEC 62304 (Software Lifecycle for Medical Devices) Fundamentals

Online, Self-Paced

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.

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

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

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