Non U.S. Based Medical Device Firms
The global medical device and diagnostics market is estimated at about $260 billion, with the United States as both the largest producer and consumer of medical devices in the world. The U.S. medical device market alone generated about $85 billion in sales in 2006 and is forecasted to grow at an annual pace of 8 to 10 percent, offering outstanding opportunities for medical technology innovators from around the globe.
One of the most important aspects of getting a medical device to market in the United States is knowing where to begin. For non US medical technology companies, especially those with novel and innovative applications, the FDA pathway can often seem complex and difficult to navigate.
With Aptiv Solutions as your partner, you will gain a deep understanding of FDA regulations, often beyond what is available in published guidance documents. Aptiv Solutions is well-respected by the FDA. Our consultants and project managers have excellent rapport with agency leaders and reviewers, earned through years of working together on a broad range of pre-market medical device submissions and client negotiations.
Aptiv Solutions will guide you through all of the phases of FDA premarket approval and clearance, design and manage your clinical trial activities, and ensure that you comply with FDA quality systems regulations for medical devices.