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.
- 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
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.
- Engineering Personnel
- Software Developers
- QA
- Management
Edwin Waldbusser, is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting in the areas of design control, risk analysis and software validation for the past 8 years. Mr. Waldbusser has a BS in Mechanical Engineering and an MBA. He is a Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness network.
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