NORTH ATTLEBORO, Mass., July 19, 2011 /PRNewswire/ -- Medical Device Consultants, Inc. (MDCI), a leading regulatory consulting firm and CRO for the medical device industry, announced today that Mr. Brian Edwards has joined the company's regulatory services group as a senior regulatory staff consultant. He will be based in Minneapolis, MN.
Mr. Edwards brings over twenty years of experience in the regulation of medical devices, design and analysis of device trials, biostatistics, quality systems, and US and OUS regulatory submissions. His work spans a broad range of therapeutic areas including work with spinal, audiological, cardiovascular, cardiology, muscle and nerve stimulation, urological, and software/communication devices. During his previous positions as director of regulatory affairs at Zimmer Spine, Inc., Otologics, LLC, and Stereotaxis, Inc., as well as a senior level position with Medtronic, Inc. he managed regulatory clearances and approvals for Class II and Class III devices in the United States, European Union, Canada, Latin America and Asia. In addition, he is experienced in the implementation and auditing of FDA and ISO compliant quality systems.
"I am pleased to welcome Brian to our team," said Vicki Anastasi, vice president of regulatory services and business development. "He brings proven regulatory expertise in key therapeutic areas, including cardiovascular, orthopedics and medical device software. Based in Minneapolis, he will amplify MDCI's presence in the important Twin Cities medical device cluster."
Brian holds a B.S. in chemical engineering, and an M.S. in biomedical engineering, both from the University of Minnesota. He also earned an M.S. in biostatistics from the University of California, Los Angeles. Brian is a member of the Regulatory Affairs Professionals Society (RAPS).
Founded in 1980, MDCI is a full-service regulatory 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. MDCI has offices in Massachusetts and California. Additional information is available at www.mdci.com.
SOURCE Medical Device Consultants, Inc.