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).
About MDCI
Founded in 1980, MDCI is a full-service regulatory consulting
firm and contract research organiza
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