U.S. Based Medical Device Firms
With over 8,000 firms, U.S. medical technology companies lead the world in medical device production. Many of these U.S. based firms also seek to expand their markets to become strong competitors globally. Some international regulatory barriers, however, especially those in developing economies, can be difficult to surmount. Medical device firms often devote tremendous amounts of time and money to determine requirements, conduct additional overseas clinical trials, and pay user fees.
While it is not possible to see products, “approved once and accepted everywhere,” Aptiv Solutions can help medical device firms to develop regulatory and clinical trial strategies that will most efficiently address requirements from a global perspective.
In addition to assisting clients with U.S. FDA regulatory, clinical trial, and quality assurance challenges, Aptiv Solutions can guide clients through the complexities of obtaining the CE mark and serves as EU Authorized Representative for clients entering the European market. Aptiv Solutions also helps clients to meet the requirements of Health Canada to enter the Canadian market.