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.
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MDIC releases Best Practices for Communicating Benefit, Risk, and Uncertainty for Medical Devices report
The Medical Device Innovation Consortium (MDIC) has announced the release of Best Practices for Communicating Benefit, Risk, and Uncertainty for Medical Devices. The intent of this report, developed by MDIC’s Science of Patient Input Communication Working Group, is to familiarize all medical device stakeholders with evidence-based practices for communicating the benefits, risks, and uncertainty of medical technology […]
MDIC recognized with RAPS 2020 Patient-Centered Health Award
The Regulatory Affairs Professional Society (RAPS) recently announced the recipients of its 2020 Founder’s Award, Community Leadership Award and Patient-Centered Health Award which are bestowed annually in conjunction with RAPS Convergence, the largest annual conference for the global healthcare regulatory community. The Medical Device Innovation Consortium (MDIC) is honored to be recognized with the 2020 Patient-Centered Health […]
MDIC releases final framework on Real-World Evidence generation for In Vitro Diagnostics
MDIC’s Clinical Diagnostics program today released the final version of its framework Real-World Clinical Evidence Generation: Advancing Regulatory Science and Patient Access for In Vitro Diagnostics (IVDs). Created through a collaborative process between MDIC, FDA CDRH, and industry partners, the framework aims to help industry and FDA consider when and how real-world data might be […]
MDIC seeks applicants for Accelerate Sustainable Capability Pilot Study
The Medical Device Innovation Consortium (MDIC) is seeking medical device manufacturers to participate in the Accelerate Sustainable Capability (ASC) pilot study, which was developed in collaboration with the medical device industry, Information Systems Audit and Control Association (ISACA), and FDA. The ASC pilot study is designed to serve as a way to help manufacturers improve […]