April 20, 2020

MDIC | Kathryn Merrill, Pilot Study Program Chair

The Medical Device Innovation Consortium (MDIC) is facilitating a collaborative effort between the medical device industry and the Food and Drug Administration (FDA) to develop an innovative pilot study that could revolutionize how sites under an enforcement action could reach and then sustain compliance. The goal of this pilot is to test a methodology for providing systemic improvement to enable compliance actions to be closed faster and more sustainably while ensuring objective metrics and residual risk assessments are in place to provide the agency oversight of product quality throughout the process.  The working group is looking for firms interested in participating in the pilot. If your organization is interested, contact Alan Baumel – MDIC Case for Quality Program Director (abaumel@mdic.org)

Learn more about the pilot study.