Overview

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

Who Will Benefit

• Engineering Personnel
• Software Developers
• QA Management

Speaker Profile