Webinars > All COMPLIANCE Categories > Compliance Courses Webinars Medical Device Software Validation Meeting FDA Regulations WebinarIn this webinar you will learn the testing that is required in addition to functional tests to produce a validated software product. Course Description/AgendaMedical 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.
Areas Covered in the Session:
Who Will Benefit:
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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