It can be a challenge to identify objectives in the research, development, and marketing of a medical device. We help you understand what steps to take in order to move your medical device to market, answering questions like — How does the regulatory process work? What challenges might arise? What are the best practices when submitting an application? How can we best navigate the process?
With deep knowledge of the various offices and divisions within the FDA, we can help you determine a high-level strategy for moving your device to the U.S. marketplace.
If you are working with the FDA for the first time — whether you are new to the medical device world or new to the U.S. regulatory process — we can help determine the appropriate pathway for your device or drug-device combination product (e.g., Pre-Market Approval, 510K, DeNovo, or Humanitarian Device Exemption).
We take the guesswork out of whom to contact at the FDA, helping you establish contact with the right people to answer your questions and facilitate the process.
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.