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.
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) […]
Applications for cybersecurity threat modeling bootcamps now open
Technical and regulatory professionals in the medical device sector are invited to attend a free two-day intensive workshop on managing cybersecurity risks in medical devices and diagnostics. MDIC plans to offer two bootcamps this year — one in the Washington, D.C., metro area and one in California — and dates and additional information about the […]