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
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,
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
Insight from Tech-Clarity’s research Servicing Medical Devices: World Class Service Management for Medical Equipment. This report is intended to help medical device companies leverage lessons learned from other service-oriented industries, but points out distinct differences in the healthcare industry.