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Compliance 4 All presents

Virtual Classroom (Live) Medical Device Software Validation Meeting FDA Regulations Webinar

In this webinar you will learn the testing that is required in addition to functional tests to produce a validated software product.

Course Description/Agenda


Medical Device Software Validation Meeting FDA Regulations

Overview:

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.


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 testing that is required in addition to functional tests to produce a validated software product.



    Areas Covered in the Session:
  • Software Validation 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

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.

 

More Webinar Information

Compliance 4 All
Compliance 4 All

Course Summary

In this webinar you will learn the testing that is required in addition to functional tests to produce a validated software product.

Delivery Method

Virtual Classroom (Live) Virtual Classroom (Live)

Who Should Attend

• Engineering Personnel • Software Developers • QA • Management

 
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Webinar Details

10/23/2019 - 10/23/2019
Tuition: $150

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Select a date from the list at the bottom of the page for specific information about that class.

Other Information
Virtual Classroom (Live)

All Date/Location Information

10/23/2019-10/23/2019 at 10:00:00 AM PDT