Approach

How an engagement runs.

Four stages, taken in the order your program needs. Every scope starts with a written estimate, and everything we produce is a document you keep.

How it starts

There is no intake product. The first conversation is how we find out whether we can help.

You write

Tell us where your program is. We reply within 12 hours with a proposed time for a call.
A short call

Where your device is, what you have tested, and what the next decision is. If your program is outside our scope, we say so on this call.
A written scope and estimate

What we will do, what you receive, and an estimate of the hours. The estimate is our best effort at the work as we understand it. It is an estimate, not a promise. If the work changes, the estimate is revised in writing before the hours are spent.
Work starts

Work is billed hourly and invoiced monthly. It starts when the engagement letter is signed and the initial payment is received. Rates and terms are set out in the letter.

Programs whose pathway is already settled start at the second stage.

Pathway review

We read your device, your intended use, and what you have tested, and write down where it lands with FDA: the classification and pathway, the evidence the agency will expect against what exists today, and the questions that should go to FDA before you spend on testing. The document is yours.
Strategy and submission plan

The open questions go to FDA in writing. The Pre-Submission package, the meeting, and the record of what the agency agreed. Then the plan: which submissions, in what order, with the test plan each one depends on.
Submission and correspondence

The IDE, the Early Feasibility Study, or the marketing submission, written by the people who did the review. Then the correspondence: every letter answered, every deadline held, until the decision.
Clinical execution

The work that surrounds the study. Sites, budgets, and clinical trial agreements. IRB coordination. Getting investigational devices into the country and onto the shelf. Design controls and the quality system, kept current alongside.

DirectlyYou deal with the people doing the work. There is no account layer and nothing is handed down.
In writingEvery recommendation is a document you keep. Calls end in a written note the same day.
To a scopeEach stage has a defined deliverable and a written estimate before it starts. Hours are invoiced monthly against that scope, and changes are agreed in writing, not discovered on an invoice.
Under confidentialityA confidentiality undertaking is signed before any technical detail changes hands. How we handle your information.

Give legal adviceCVRA is a regulatory consulting firm, not a law firm. Where you need counsel, we will say so.
Promise outcomesFDA decides. We can make the submission as strong as the evidence allows, and we will tell you when the evidence is not there yet.
Take the sponsor's seatYou hold the IDE and the obligations that come with it. We prepare the work and manage the exchange; you sign.
Work outside our scopeCardiovascular devices and FDA. If your program is elsewhere, we will tell you on the first call.

A reply within 12 hours, a short call, and a written scope and estimate before any work starts.