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Adds new reg, QA capabilities to device clinical trial management portfolio
August 22, 2011
By: Gil Roth
President, Pharma & Biopharma Outsourcing Association
Aptiv Solutions has acquired Medical Device Consultants, Inc. (MDCI), a provider of medical device consulting and clinical trial management and execution. The acquisition adds complementary regulatory and quality assurance capabilities to our portfolio of offerings as well as strengthening Aptiv’s existing clinical trial management services, according to a company statement. Founded in 1980, MDCI has developed, prepared and submitted more than 600 successful 510(k)s, participated in the development of more than 20 successful PMAs, and managed hundreds of clinical trials to support medical device approvals and clearance in a number of global markets. Aptiv’s chairman and chief executive officer, Patrick Donnelly, said, “We look forward to leveraging the unique expertise of MDCI’s 30-year success with our existing portfolio of device and diagnostic consulting offerings, across a broad array of therapeutic areas. We are delighted to welcome the seasoned group of medical device and diagnostic experts from MDCI to the company, as we continue to broaden our acumen in medical device and adaptive trial methodology.” Bill Morton, MDCI’s president and founder, added, “We are thrilled to join Aptiv Solutions. This transaction is the result of an extensive and detailed search by both parties to identify the optimal partner. I am confident that by joining MDCI’s core medical device expertise with the leadership position of Aptiv Solutions, clients of both firms will receive expert, comprehensive and integrated regulatory affairs and clinical trial support for innovative medical device and diagnostics products now and in the future.”
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