We are here to help streamline the FDA application process and increase the probability of success in reaching the U.S. marketplace.
We assist in the groundwork before submitting to the FDA and supporting agency engagement over the total product life cycle of the medical device. We can focus your engagement with the FDA, whether we assist in pre-submission or in helping prepare your final submission.
We can help build an outline for your submission and assist with the development of your regulatory strategy.
If you haven’t submitted to the FDA before, we can help every step of the way, introduce you to the process, identify the appropriate contacts, and support your idea to reality.
The Jacobs Institute is focused on accelerating the research, design, development and manufacture of innovative high-quality, clinically relevant engineering solutions and products to impact the treatment of vascular, neurological, and related diseases.
We are registered to ISO 13495:2016 by SRI Quality System Registrar. Learn more about our quality management system
Get to Know Our Regulatory Process
Carlos Peña, PhD, MS, is Chief Regulatory Officer and Chief Quality Officer, leading the newly-established Offices of Regulatory Services and Office of Quality Services at the Jacobs Institute. Carlos served 20+ years as a public servant in federal government. Prior to the JI, Carlos served as the Director of the...
The JI is proud of its strong ties with its medical industry partners. Through these collaborations, we are able to provide excellence in medical device innovation, training, and educational programs.