RESTON, Va.--(BUSINESS WIRE)--Aptiv Solutions announced today the acquisition of Medical Device Consultants, Inc. (MDCI), a provider of expert medical device consulting and clinical trial management and execution. Aptiv Solutions is one of the leading providers of clinical trial management services to the medical device industry. This acquisition adds new complementary regulatory and quality assurance capabilities to our portfolio of offerings as well as strengthening our existing clinical trial management services.
Founded in 1980, MDCI has offered regulatory, quality assurance, compliance, and clinical trial management services to the medical device and diagnostic industries. MDCI is a recognized leader in addressing regulatory and clinical trial requirements for emerging growth firms and well-established medical device and diagnostic innovators. The company has developed, prepared and submitted more than 600 successful 510(k)s, participated in the development of over 20 successful PMAs, and managed hundreds of clinical trials to support medical device approvals and clearance in the US, Europe, and around the globe. This acquisition brings a strong team of dedicated professionals adding depth and breadth to the Aptiv Solutions medical device consulting and clinical trial services business. Aptiv Solutions has offered clinical trial management services to the medical device industry since 1983, helping clients earn 32 PMA and HDE approvals through innovative designs accompanied by full-service clinical trial support and site management.
The increased rigor demanded by regulatory agencies around the world for medical device development and approvals requires the expertise and scale of a global service provider with focus on the unique aspects of medical devices. With the addition of MDCI’s deep knowledge base, Aptiv Solutions will provide an enhanced range of strategic consulting and medical device trial experience to current and prospective clients.
With the transaction complete, Aptiv Solutions Chairman and CEO Patrick Donnelly said: “We are excited to announce the acquisition of MDCI, one of the premier medical device consulting firms. We look forward to leveraging the unique expertise of MDCI’s thirty-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, President and Founder of MDCI, 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.”
About Aptiv Solutions
Aptiv Solutions is a global biopharmaceutical and medical device development services company focused on recognizing, understanding and enabling clients to capitalize on rapid and fundamental changes facing companies developing products in the pharmaceutical, biotech and medical device market. The company offers clients an extensive portfolio of innovative services including adaptive clinical trial design and execution, medical device consulting and trial execution, early phase product strategy, regulatory services, pharmacovigilance, clinical staffing and the operational support of a global clinical research organization. Aptiv Solutions has over 750 professionals in North America, Europe, the Middle East, Japan, and Australia, and operates out of 23 offices in 17 countries. Visit the Aptiv Solutions website at www.aptivsolutions.com.
About MDCI
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.