Medical Device Software Validation Meeting FDA Regulations

  • Tuesday
  • June
  • 18
  • 2024
10:00 AM PDT | 01:00 PM EDT
60 Minutes
Edwin Waldbusser Instructor:
Edwin Waldbusser
Webinar Id:

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Price Details
$149 Live
$299 Corporate Live
$199 Recorded
$399 Corporate Recorded
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Live + Recorded
$299 $348 Live + Recorded
Corporate (Live + Recorded)
$599 $698 Corporate
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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 and how to use ISO62304 to establish risk level. How software requirements are used in validation will be described. We will discuss risk based testing and the amount of documentation, based on risk, to be submitted to the FDA, following the 2023 Guidance.

Why should you 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 risk based testing that is required to produce a validated software product and the documentation to be submitted to the FDA.

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

Areas Covered in the Session:

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

Who Will Benefit:
  • Engineering Personnel
  • Software Developers
  • QA Management

Speaker Profile
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 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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