8/1/2018– MDICx Series: CDRH Critical to Quality Initiative WEBINAR! Register today!
8/15/2018– MDICx Series: Designing patient-centered clinical trials: Results of the MDIC project to use patient preference information to design clinical trials WEBINAR! Register today!
9/5/18 – MDIC’s 2018 Annual Public Forum will be held in Washington, D.C. Register today!
9/12/18– MDICx Series: Q3 Quarterly update on the CDRH Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program WEBINAR! Register today!
7/16/2018 – The National Evaluation System for health Technology Coordinating Center (NESTcc) has announced two new funding opportunities, including a call for concepts for its second round of test-cases as well as an opportunity to submit targeted test-case concepts leveraging patient-generated health data for regulatory purposes. Read More.
7/3/2018 – Upon creation of the Surrogate Sample Framework, MDIC’s working group developed a comprehensive set of educational materials to assist with shared terminology and principles for the acceptable use of surrogate samples between FDA reviewers and IVD test developers. The Harmonized Education materials developed by the MDIC Surrogate Samples working group.
Focused on the Medical Device Ecosystem
MDIC is the only public-private partnership (PPP) focused exclusively on the strategic needs of the medical device ecosystem. MDIC is designed to create a collaborative environment where the industry, nonprofit organizations, and government can work together to advance pre-competitive medical device research so that the medical device community can keep pace with the needs of patients in the United States in a more timely manner.
Focused on Regulatory Science
Regulatory science refers to the development and evaluation of new tools, methods, standards, and applied science that support a better understanding and improved evaluation of product safety, quality, effectiveness, and manufacturing throughout the product life cycle.
Focused on Improving Health
MDIC has been formed to add value at the intersecting needs of the medical device industry, the FDA, and the related organizations that are together responsible for a vibrant medical device industry that serves the public health needs of the United States.