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This course will teach how to conduct a software validation program 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. This course is not a programming course. We will discuss what must be done but will not discuss methods to execute necessary testing.


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


Testing software to prove that it works and has no bugs is not sufficient to obtain FDA approval. There are additional requirements, 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 requirements in addition to functional tests that are required to produce a validated software product.


  • How to properly plan Verification and Validation activities.
  • Verification & Validation testing throughout the product life cycle.
  • How to determine sample sizes needed for testing.
  • What is appropriate objective evidence.
  • How to perform regression analysis.
  • What is meant by Production Equivalence.
  • How do we validate test methods.
  • Special considerations for software based products


  • Software Developers
  • Software Engineers
  • IT Personnel
  • Device Development Managers
  • Systems engineers responsible for developing requirements
  • Test Engineers
  • Quality System auditors
  • Quality System auditors


Edwin Waldbusser is a consultant retired from industry after 20 years in management of development of medical devices (5 patients). 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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