About
A focused firm, on purpose.
Cardiovascular Regulatory Advisors, Inc. is a regulatory and clinical consulting firm for medical device startups entering the United States.
- Cardiovascular devicesDeepest experience in Class III implants.
- The US pathwayFDA only. If your route is elsewhere, we say so on the first call.
- First-in-human to marketPre-Submission, IDE and Early Feasibility Study, through to PMA.
Who we are
Most regulatory consultancies are broad. They cover every device class, every jurisdiction, and every stage, and they staff startup work with the least experienced people they have. Registration agents are cheaper and file paperwork competently, but they have no clinical depth and cannot help when FDA pushes back.
We chose the opposite shape. Cardiovascular devices, the US pathway, and the stage between first-in-human and market. The people who write your submission are the people who answer the agency on it, and they are the people you met on the first call.
What we are not is just as defined. We do not take work outside FDA and quality systems, and we do not certify a quality system: we prepare and remediate the documentation, and an accredited body issues the certificate.
Experience
We have significant experience taking Class III cardiovascular devices through IDE with FDA, the clinical stage on which a PMA is ultimately built. CVRA works on PMA-pathway programs from the Pre-Submission onward.
Who you'll work with
CVRA's regulatory and clinical work is led directly by the firm's principal. The principal served as the sponsor-side regulatory lead for a Class III cardiovascular implant entering the United States: preparing the Pre-Submission strategy and the IDE and Early Feasibility Study application, authoring the sponsor's responses to FDA deficiency feedback, and managing the program's start-up at two of the highest-ranked cardiac programs in the United States, including site budget and clinical trial agreement negotiation, IRB coordination, and investigational device import. The principal holds a graduate degree from Carnegie Mellon University, awarded with Highest Distinction, and has a background in engineering.
Every engagement is staffed by the principal. There is no hand-off to a junior team.
Sponsors we work with
Medical device startups and first-time sponsors, usually at the point where the bench data is in and the next step is a conversation with FDA. If your device is not cardiovascular, or your pathway is not in the United States, we will tell you on the first call and, where we can, point you to someone better placed.
Regulatory status
Cardiovascular Regulatory Advisors, Inc. is a regulatory consulting firm. It is not a law firm and does not provide legal advice. It is not affiliated with, endorsed by, or acting on behalf of the U.S. Food and Drug Administration. Regulatory outcomes depend on the evidence and on the agency's review, and cannot be guaranteed.
Client work is confidential. We do not name clients, describe their devices, or publish case studies, and nothing on this site describes any client's program.
Tell us where your program is.
We reply within 12 hours. You get a written scope and estimate before any work starts.