About Novare.

Novare was founded in 2021 by medical device industry veterans — people who didn't just do the work, but led it. Our Principals have been the engineers building Design History Files (Design and Development Files), the quality leaders running systems through audits, the regulatory directors defending submissions, and the executives sitting across the table from FDA and notified bodies.

That means we understand what you're facing — not from outside it, but because we've been there. We know what it feels like to be the person responsible for getting a device to market on time, defending decisions to a CEO or Board of Directors, and answering hard questions when an inspector/auditor arrives.

And we don't just hand off deliverables and walk away. We work alongside your team — designing systems together, teaching as we go, and staying close as you build independence. The goal isn't to make you dependent on Novare. It's to help your team walk on its own, and then run.

Today, Novare serves venture-backed startups submitting their first 510(k), established manufacturers remediating Design History Files (Design and Development Files) under EU MDR, growth-stage companies scaling quality systems for the first time, and global operators navigating multiple regulatory jurisdictions.

Novare engagements are led by Principals. Day-to-day work isn't delegated to junior consultants. The person scoping the engagement is the person doing the work — and the person responsible for the outcome.

When additional capacity or specialty expertise is required, we draw on a vetted network of senior subject matter experts. They're industry-experienced, screened by a Principal, and engaged on the specific projects where their expertise fits — never assigned blindly.

This model has practical implications. Our engagements tend to be deeper and more concentrated than typical consulting arrangements. We don't try to be everywhere; we go deep where the work matters most.