• Medical Device Software Validation Meeting FDA Regulations
  • Medical Device Software Validation Meeting FDA Regulations

    • Speaker : Edwin Waldbusser
    • Session Code : EWOCT2522
    • Date : 25th October 2022
    • Time : This Event is Over and the Recorded Content is Available
    • Duration : 75 Mins



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 for Participants - software traceability matrix form, validation plan template, and validation report form


By attending this webinar participants will learn:


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

Why should you attend?


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.


Who will benefit?

  • 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 US and internationally in the areas of design control, risk analysis and software validation for the past 11 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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Tags: Medical Device, Software Validation, FDA Regulations, Edwin, Waldbusser, October 2022, Webinar