Tech-Clarity research shows that the majority of manufacturers believe that digitalization is important or critical to achieving their business strategy (see figure). Over one-third say that it’s critical. Digitalization in medical device design and manufacturing has significant promise, but what does it actually mean? Medical device companies, already struggling with how to address critical initiatives…
DHF
Digital Design Control for Medical Devices
Medical Device companies have to manage complexity and regulation without placing excess overhead on their designers. Devices complexity has led to increased complaints, CAPAs, observations, and recalls. The root cause is frequently insufficient and cumbersome design control. Digitalization helps them design with agility while maintaining control. It improves speed, accuracy, and productivity by automating submissions,…
Does Quality Management Belong in PLM? (eBook)
The Does Quality Belong in PLM? eBook explores the value of implementing quality management processes in a Product Lifecycle Management system. The research shares perspectives from several manufacturers about managing quality processes like CAPA and creating product documentation including Design History Files (DHF) and Design Master Records (DMR). The eBook looks at the value of using standalone Quality…