O'Connell & Myers was established in 2018 with the goal of helping start-ups and small medical device companies navigate the FDA's regulatory process to get their first FDA clearance or approval, to set up their Quality Management Systems, or to assist manufacturers who lack expertise in the design control aspect of regulatory affairs. In addition we specialize in helping international manufacturers and distributors obtain the FDA approvals necessary to introduce their medical devices into the United States market. When you choose to work with O'Connell & Myers, we know that the devices that enter the marketplace will carry your reputation as well as ours. This is a matter that we take extremely seriously because we are only successful when you are successful.