Medical Device Companies We Serve
Small entrepreneurial firms drive medical device innovation, but often struggle with limited funding and inadequate resources. Aptiv Solutions is a vital partner to help you identify and overcome obstacles, avoid costly development delays and speed your journey from product concept to commercialization.
Large established companies, who are responsible for over half of all medical device industry revenues, must continually adapt to technology advancements, while maintaining product integrity and reliability. Aptiv Solutions can help you to stay ahead of the competitive curve, balance risk, and stay focused on your overall business objectives.
In addition to helping you address U.S. FDA regulatory, clinical trial, and quality assurance challenges, Aptiv Solutions can also assist with CE marking
and help you to identify you’re an EU Authorized Representative as you expand into Europe.
The U.S. medical device market is first in the world and continues to expand, offering opportunities for innovators from around the globe. Aptiv Solutions can guide you through all phases FDA premarket approval and clearance, manage your clinical trial activities and ensure that you comply with FDA quality systems regulations.