Process Development and Quality Systems for Medical Devices

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).