Process Development and Quality Systems for Medical Devices

BIOENGR X 430.3

Gain a foundation for medical device industry professionals seeking to solidify their understanding of quality systems requirements and applications.

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What you can learn.

Identify best practices to address requirements for product design and process development
Develop a product design and perform risk management activities
Design validation and verification activities
Design transfer to manufacturing
Establish a controlled manufacturing process

About this course:

This course provides a foundation for medical device industry professionals seeking to solidify their understanding of quality systems requirements and process development best practices. This enables students to successfully engage within medical device product development teams in an industry setting, scope efforts appropriately, and reduce compliance risks. The course focuses on identifying best practices to address the relationship between product design and process development. Students learn an overview of design controls, requirements for medical device process validation, statistical tools used to characterize and optimize processes and designs, process validation and strategies to develop robust manufacturing processes, and use of statistical software (Minitab).