When developing novel technologies, the identification of challenges as well as potential paths forward in bringing a medical device to market are extremely important. We assess the uncertainty you may face when moving from idea to reality via a clinical study and help to identify solutions to mitigate those risks and facilitate regulatory engagement.
We will evaluate your strategy for submitting to the FDA, as well as your submission, while considering the type of device technology and your stage or status in the submission process.
Let us review what you have submitted to the FDA, to help you anticipate regulatory feedback and potential challenges.
In addition to identifying potential challenges with bringing your ideas to reality, we propose solutions that enable a path forward. We can identify potential solutions and provide you with trusted partners along the way.
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.
The Jacobs Institute is certified to ISO 13485:2016, demonstrating compliance with international quality system requirements for the research, design, development, and manufacture of vascular and related medical devices and anatomical models, and for the delivery of engineering, validation, testing, simulation, and related technical services.
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.