PTC Executive Exchange - PLM in Healthcare
Accelerating Medical Device Innovation While Mastering the FDA Case for Quality – The Vital Role of PLMWe live in an age where innovation is driven by Digital Transformation. Medical Device Companies are facing the unique challenge of remaining competitive in an environment where increasing regulatory complexity is coupled with the demand for lower cost medical innovations in a connected world.Intense analysis of device quality data and feedback, from regulatory and industry stakeholders led the FDA to establish the Case for Quality. The objective being the advancement of medical device quality and safety to achieve better patient outcomes. The Case for Quality elevates the focus of medical device stakeholders from baseline regulatory compliance to sustained, predictive practices. This will inevitably lead to changes in procedures for product design and development.How can Medical Device Companies master the FDA Case for Quality in a time when Digital Transformation of the industry lea