Free tools for the questions medical device teams ask before they spend on development. Each tool answers one question with public data or our published numbers, works without sign-up and keeps your answers in your browser. When you are ready, the cost calculator and a 30-minute call turn the answer into a plan.
How these tools work
- Public data with a date. Regulatory numbers come from FDA, the Federal Register, eCFR and EUR-Lex. Every tool page shows its sources and the date of the data.
- Plain logic, no AI. The tools use fixed rules and published data. They do not generate text and do not guess.
- An orientation, not an opinion. The tools help you prepare for a conversation with FDA, a notified body or your regulatory specialist. They do not replace it.
- Private by default. 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.
What OVA does here, and where our responsibility ends
OVA Solutions is a medical device engineering group working under an ISO 13485:2016 certified quality system: 62 engineers, 220 devices developed, $125 per hour. We design electronics, firmware and mechanics and take a device 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.
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.