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.
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
attending this webinar participants will learn:
validation is more than testing
integration and system testing
to the software
should you attend?
course will teach how to conduct a software validation program for medical
devices containing software that will satisfy FDA requirements and produce a
will explain the role of risk analysis in validation.
software requirements are used in validation will be described.
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.
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.