A training package for an introduction to medical device quality for technical professionals.

摘要

This five-day seminar outlines basic Quality and Regulatory concepts and requirements as applied to the development of Medical Devices. Microsoft PowerPointeRTM slide presentations include supplemental materials for class workshops and break out sessions. The object of the training is to instruct the participants on product and process validation requirements as well as to provide tools for more effective validation. Quality and statistical tool classes include Failure Modes and Effects Analysis, Components of Variation Study, Reliability, Control Charts and Process Capability.