• Online, Self-Paced

Learning Objectives

  • Understand FDA software validation guidelines.
  • Apply the principles of software validation in medical devices.
  • Develop a software validation plan.
  • Perform testing and documentation for software validation.
  • Understand the regulatory requirements for software validation.

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):