Free tools for the questions medical device teams ask before they spend money on development. Each one answers a single question in a minute or two, from FDA, EU or grant data, with no sign-up. When the answer raises the next question, the cost calculator and a 30-minute call turn it into a plan.

How the tools work

  1. Public data with a dateNumbers come from FDA, the Federal Register, eCFR, EUR-Lex and the grant agencies, and every page shows its sources.
  2. Fixed rules, no AIThe tools follow published rules and data. They do not write text or guess.
  3. Your answers stay with youEverything runs in your browser; analytics only count that a tool was used.

What OVA does here, and where our responsibility ends

220devices developed62engineers$125per hourISO 13485certified quality system

We design the electronics, firmware and mechanics of medical devices and take them from concept to design for manufacturing. We are not a regulatory consultancy and not a contract manufacturer: the regulatory strategy and the submission stay with you or your regulatory consultant.

The result is an orientation, not a regulatory opinion. Confirm the pathway with a regulatory specialist or through a Pre-Submission (Q-Sub) with FDA. The tool runs in your browser. Your answers are not sent to us; with your cookie consent, Google Analytics records only that the tool was used and the category of the result.

Want a plan for your device?

Tell us where your device is today. Lisa Voronkova will go through it with you; after an NDA, our CTO reviews the design and we send an estimate in hours by phase.

By Lisa Voronkova, CEO of OVA Solutions. Updated on October 22, 2026.