MDIC is the only public-private partnership (PPP) developed to work with government and industry stakeholders in an effort to advance solutions that promote patient access to innovative medical technologies.
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MDIC is the only public-private partnership (PPP) developed to work with government and industry stakeholders in an effort to advance solutions that promote patient access to innovative medical technologies.
FDA Commissioner Dr. Stephen M. Hahn to headline MDIC’s Annual Public Forum
On June 18th, FDA Commissioner Dr. Stephen M. Hahn will headline MDIC’s 2020 Annual Public Forum, to be held virtually this year. The Annual Public Forum is MDIC’s premiere event where the medical device and diagnostics community convenes to discuss current trends in regulatory science and highlight innovative regulatory science tools and industry priorities. The […]
MDIC releases draft framework on Real-World Evidence generation for In Vitro Diagnostics for public comment
MDIC is seeking public comment on its framework Real-World Clinical Evidence Generation: Advancing Regulatory Science and Patient Access for In Vitro Diagnostics (IVDs). This framework was established following the release of the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) Guidance, “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical […]
MDIC Initiates Pilot Study to Strengthen the Performance of Struggling Sites
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 […]
MDIC Initiates CAPA Process Improvement Pilot for Medical Device Manufacturers
MDIC | Kathryn Merrill, CAPA Process Improvement Program Chair This past year the Medical Device Innovation Consortium (MDIC) facilitated a collaborative effort of the medical device industry, strategy consultants, and the Food and Drug Administration (FDA) to bring together cultural and procedural best practices across various industries to recast the Corrective and Preventive Action (CAPA) […]