• 2016 Pediatric Medical Device Competition

    Six innovations win $250,000 grants at Pediatric Surgical Innovation Symposium.  » Full Story

  • Maryland's biotech corridor

    M-CERSI is located within an hour’s drive from many of the nation’s top bioscience research forces—including the National Institutes of Health (NIH), Walter Reed National Military Medical Center, and the University of Maryland School of Medicine—as well as a number of biotech industry leaders.

  • On Tuesday, March 7, 2017, the University of Maryland (UMD) Robert E. Fischell Institute for Biomedical Devices and RTI International welcomed nearly 150 representatives of Maryland’s medical device ecosystem to a daylong event focused on bringing products from invention to market in the state. 

  • Taking place May 15-17, 2017, Dissolution and Translational Modeling Strategies Enabling Patient-Centric Product Development is a multi-day public conference designed to clarify the utility of dissolution and modeling/simulation approaches. » Learn more.

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  • A. James Clark Hall

    A. James Clark Hall, a 184,000-square-foot state-of-the-art facility, will serve as home to UMD's Fischell Department of Bioengineering and the Robert E. Fischell Institute for Biomedical Devices, beginning 2017.

About M-CERSI

The University of Maryland's Center of Excellence in Regulatory Science and Innovation (M-CERSI) is funded by the U.S. Food and Drug Administration (FDA). The center focuses on modernizing and improving the ways drugs and medical devices are reviewed and evaluated.

The center is a collaborative partnership between the University of Maryland, College Park, and the University of Maryland in Baltimore. Researchers from both campuses work with FDA staff to support the development of new tools, standards and approaches to assess the safety, efficacy, quality and performance of FDA-regulated products. Through the M-CERSI, researchers, regulators and industry professionals can learn from one other in the effort to develop regulatory science practices that promote innovation in medical devices and pharmaceuticals, while also addressing critical safety concerns.

This website highlights regulatory science activities at the center and coalesces center research projects into an information-rich resource base. The site will be populated with articles and opinion statements by M-CERSI researchers.
 


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