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. How software requirements are used in validation will be described.

Why you should 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 testing that is required in addition to functional tests to produce a validated software product.

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

Areas Covered in the Session:

• Software Validation more than Testing
• Requirements Traceability
• Risk Analysis
• Unit, Integration and System Testing
• Algorithm Validation
• Challenges to the Software
• Configuration Management

• How to validate medical device software in compliance with FDA objectives

• Engineering Personnel
• Software Developers
• QA
• Management