News
January 6, 2009
Mark Sheehan, MDCI Regulatory Associate Achieves RAC Certification
Medical Device Consultants, Inc. (MDCI) a leading regulatory consulting firm and CRO for the medical device industry, today announced that Mark Sheehan, Regulatory Associate, received Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society (RAPS).
According to RAPS, which administers the RAC testing and certification, "The RAC designation is a mark of professional distinction, indicative of the professional and technical abilities that are vital in this time of increasing challenges and demands within the health product sector. It also identifies individuals committed to excellence, pursuit of knowledge and career development." The only certification for regulatory professionals in the healthcare product sector, the RAC addresses laws, regulations, policies and guidelines affecting regulated health products, including medical devices, pharmaceuticals, biologics and biotechnology in the U.S., EU and Canada.
"MDCI congratulates Mark on achieving the professional recognition of RAC certification," said Vicki Anastasi, Director of Regulatory Affairs. "Mark brings a wealth of regulatory affairs experience that has been an asset for our clients. Specifically, Mark has played an integral role in helping clients with novel technologies address the evolving FDA requirements for innovative medical device products in the areas of diabetes management / glucose monitoring, pain management and wound care / wound healing."
Mark began his regulatory affairs career in 2004 and has experience with a variety of therapeutic areas and medical specialties. He works closely with medical device clients to address FDA premarket requirements. Mark holds two M.A’s in Philosophy from San Diego State University and the University of California, Davis and a B.A. in Philosophy from the University of Massachusetts, Amherst.
About Medical Device Consultants, Inc. (MDCI)
MDCI is a full-service consulting firm and contract research organization (CRO) that helps emerging and established firms commercialize novel and innovative medical devices, in vitro diagnostics, and combination products. Clients trust MDCI to deliver customized strategic guidance and creative "hands-on" solutions to address their unique regulatory, clinical trial, and quality assurance challenges at every stage of the product lifecycle.
MDCI has helped hundreds of clients conduct successful clinical trials, achieve regulatory clearance and approval, and maintain compliance for products in the U.S. and internationally. By leveraging our comprehensive knowledge of FDA and international regulations, clients capture and grow market share, increase productivity, and stay competitive in an increasingly complex global marketplace.
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