FDA, MDIC Eye Technology Clearinghouse For Advanced Manufacturing
The US FDA is teaming up with the Medical Device Innovation Consortium to establish the clearinghouse, which would nudge medtech companies to adopt novel approaches that could take their manufacturing operations to a higher level.
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The US FDA’s Resilient Supply Chain Program (RSCP) will be housed in the agency’s Office of Strategic Partnerships and Technology Innovation and aims to reduce future supply chain shortages by applying lessons learned during the pandemic.
The draft document from the US agency looks to officially recognize a program aimed at advancing quality in medical devices and their manufacturing.
Chasing Quality Isn't Easy. But An FDA Pilot Aims To Boost Quality By Appraising The Capability Of Manufacturing Sites
The pursuit of quality can be a daunting task for device-makers. One wrong step can cause costly product recalls affecting patient health – among other troubles tied to poor quality products and processes. To help firms move toward a goal of best-in-industry quality, US FDA, through its Case for Quality initiative, has convened a pilot program to measure a manufacturer's capability and maturity to help put it on a path to continuous improvement. The pilot uses an industry-tailored version of the Capability Maturity Model Integration (CMMI) model and method, developed jointly by FDA, industry and CMMI Institute.