Medical Device Services
In today’s global marketplace, the development and marketing of medical products is a highly regulated process with strict governmental requirements. Since 1980, Aptiv Solutions has provided regulatory, clinical, and quality assurance consulting services to help medical device and in vitro diagnostic product manufacturers meet those requirements.
Our client engagements number in the thousands and represent almost every therapeutic area and medical device specialty area, for both U.S.-based and international clients. By leveraging our comprehensive knowledge of FDA and EU (IVDD, MDD, AIMDD) and international regulations, you can capture and grow market share, increase productivity, and stay competitive in an increasingly complex global marketplace.
Whether you need a CRO to define your FDA, EU or international regulatory pathway, to support your product with a well-designed clinical trial, to prepare your team for an FDA QSR or ISO 13485 audit, or ensure ongoing compliance, count on Aptiv Solutions for the experience and knowledge to lead you to success.