Medical Device Software Validation Meeting FDA Regulations

This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product.

We will explain the role of risk analysis in validation and how to use ISO62304 to establish risk level. How software requirements are used in validation will be described. We will discuss risk based testing and the amount of documentation, based on risk, to be submitted to the FDA, following the 2023 Guidance.

Why should you Attend: Testing software to prove that it works and has no bugs is not sufficient to obtain FDA approval. There are additional analyses and tests that FDA feels are necessary to prevent user injuries. These requirements were developed after analysis by the FDA of many recalled medical devices. In this webinar you will learn the risk based testing that is required to produce a validated software product and the documentation to be submitted to the FDA.

Handouts are software traceability matrix form, validation plan template, and validation report form


Areas Covered in the Session:

• Software validation is more than testing
• Requirements traceability
• Risk analysis
• Unit, integration and system testing
• Algorithm validation
• Challenges to the software
• Configuration management

• Engineering Personnel
• Software Developers
• QA Management