History
O'Connell & Myers was established in 2014 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.
O'Connell & Myers follows current regulations and guidances to provide accurate and fair regulatory advice to all customers. 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.
Get in touch
We at O'Connell & Myers know that partnering with the right regulatory consulting firm can save you time, money and market opportunity.
We offer free consultations to understand your device, timeline and budget.