Process Development and Quality Systems for Medical Devices
BIOENGR X 430.3
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Gain a foundation for medical device industry professionals seeking to solidify their understanding of quality systems requirements and applications.
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 will provide a foundation for medical device industry professionals seeking to solidify their understanding of quality systems requirements and process development best practices. This will enable them to successfully engage within medical device product development teams in an industry setting, to scope efforts appropriately and reduce compliance risks. The course will focus on identifying best practices to address the relationship between product design and process development. Students will learn: 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).