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Conducting a Software Validation of Medical Device to Meet FDA Requirements

Compliance Key INC - Medical Device Training


                                          Edwin Waldbusser
Ed is Keynote Speaker at Compliance key Inc. He is retired from industry after 30 years in management of development of medical device products and development of company Quality Systems. Products included IVD devices, kidney dialysis systems and inhalation devices. QS experience includes design control, risk analysis, CAPA, software validation, supplier qualification/ control and manufacturing. 
 Webinar Id: LSHCMEW007
 10.00 AM PT | 01.00 PM ET
 12/04/2017
  Duration 90 mins 
Overview
This course will teach how to conduct a software validation program that will satisfy FDA requirements and produce a safe product. Software validation is much more than testing.We will explain the role of risk analysis in validation. How software requirements are used in validation will be described.
Why should you attend this webinar?
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.
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 can Benefit:

  • Development Engineers
  • Engineering Management
  • QA/QC personnel
  • Software developers
Labels:
Location: United States

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