ASC Program Pilot Study: Raising the Bar for Quality Standards in Medical Devices

The Accelerate Sustainable Capability (ASC) pilot study, facilitated by MDIC alongside the FDA and industry partners, explores a strategic approach to strengthening quality management systems (QMS) with a focus on sustainable, long-term enhancements. 

Insights from the MDIC Excellence in Quality Summit

The MDIC Excellence in Quality Summit brought together industry leaders, regulatory authorities, and quality professionals, all committed to advancing quality practices throughout the medical device lifecycle. Over two days, the Summit explored innovative strategies and shared insights that emphasized the critical importance of integrating a culture of quality within organizations, harnessing advanced technologies, and continually striving for improvement.

Latest Clearance Success for Intuitive Powered by NEST Mark

The NEST Mark initiative which is being developed by the National Evaluation System for health Technology (NEST) has succeeded in empowering yet another efficient and streamlined path to FDA clearance for Intuitive labeling modification for its previously cleared robotic-assisted surgical devices (RASD) da Vinci Xi and X Surgical Systems.