Software Validation for the New FDA Inspections
Learn to run a software validation program that satisfies FDA requirements, using requirements traceability, risk analysis, layered testing and configuration management.
Speaker
Edwin Waldbusser
Medical device consultant · 20 years in medical device development
Overview
FDA software validation takes more than proving that code works and is free of bugs. This 60-minute webinar explains how to run a software validation program that meets FDA requirements and produces a safe product.
You'll learn how software requirements drive validation, why requirements traceability matters, and the role of risk analysis. The session covers unit, integration and system testing, algorithm validation, challenging the software, and configuration management. It is not a programming course: it explains what must be done rather than how to carry out the tests.
Why attend: Functional testing alone is not enough for FDA approval. The FDA expects additional requirements, analyses and tests aimed at preventing user injuries, developed from its analysis of many recalled medical devices. This session suits engineers and engineering managers, software engineers, programmers, and quality assurance and regulatory professionals.
What’s covered
- Why software validation is more than testing
- Requirements traceability
- Risk analysis
- Unit, integration and system testing
- Algorithm validation
- Challenges to the software
- Configuration management
Who should attend
What you get
About the speaker
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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