With more than 30 years of experience in the medical device industry, I offer clients strategic and sound regulatory guidance.
I approach my work as a partnership, focused on your vision and creating a regulatory strategy to help you get to market.
— Michael Morton, FOUNDER
Michael Morton participating as part of a panel for the Sheikh Zayed Institute for Pediatric Surgical Innovation.
I focus first on strategic regulatory planning. I have a passion for higher risk, Class III, Pre-Market Approval (PMA) products. I also have expertise in the 510(k) and de novo processes.
In my medical device experience, I’ve worked with products from concept to pre-clinical and clinical testing, through the regulatory approval process, the post-market phase, redesign and new iterations. I can support you throughout the total product life cycle.
One of the greatest challenges in bringing products to market is the U.S. Food and Drug Administration advisory panel meeting. I’ve organized and prepared sponsors, and I’ve presented at panel meetings. I served as the industry representative for the Circulatory Devices Advisory Committee, and I received an FDA service award for this work. I have participated in over 50 panel meetings.
I also have direct experience and knowledge across numerous therapies and device types, including spinal, dental, neurological and cardiac rhythm management. My core competency is in cardiovascular devices such as heart valves, coronary and endovascular stents.