FormlyAI is now Dovetail.

Here's what's changed, and why.

We started building a compliance platform for medical devices. A good one, built by regulatory people who were tired of software that stored documents but never helped write them. It was the first of its kind, it combined generative AI, an eQMS and technical documentation. That was the right place to start. It is not where we've ended up.

Today we're announcing that FormlyAI is becoming Dovetail.

Here is the short version, because you're busy and the rest of this is the reasoning.

• Formly is now Dovetail. New name, same company, same people.
• Our embedded regulatory service is now Envoy. The senior team we embed into yours to take you from pre-market to clearance.
• The platform is now Dovetail QMS Plus. Our eQMS and the AI agent carry on in their current form, with regular improvements. Same logins, same data, same roadmap.

Nothing about how we work changes. What changes is that the name now tells the truth about what we've become.

Why a new name at all

"Formly" was a nod to the forms you fill to get a device cleared, and at "conform", which is exactly what a company has to do to win clearance. The name did its job. But conforming is the bare minimum, and over the years what we actually do stopped being "a place to keep your documents" and grew into something else. So we broke free from the cage (that's the last bird reference, we promise, we just had to get it out of our system).

We pair senior regulatory experts, many of them ex-FDA, with an agentic AI trained on live regulation, sitting on top of an eQMS those same experts use every single day. Not three products in a trench coat. One integrated system, where the AI does the tedious drafting and searching, the expert keeps judgement and accountability, and the eQMS is where it all lands as audit-ready evidence.

The experts make the AI trustworthy. The AI makes the experts faster. The eQMS is built by the people relying on it, so it reflects how the work actually gets done. We do this seamlessly enough that clients stop noticing the seams. That is the whole point, and it is exactly what "dovetail" describes.

What "dovetail" actually means

A dovetail joint is one of the oldest forms of precision joinery. Two pieces of wood cut to interlock so tightly they hold without glue. It isn't decorative but structural. The name signals craft, precision, and parts that genuinely fit together, without having to say any of those words out loud.

We chose Dovetail because it describes what we do at every level at once.

Our AI dovetails into the expert's workflow, augmenting their judgement instead of replacing it. The expert dovetails into your team, integrating cleanly rather than parachuting in as a disconnected consultant. And when everything is aligned, your device dovetails into the market. One name, working on every layer.

The four-fold dovetail effect

Stack those layers and you get the chain that actually gets a device approved.

Each link only works if it locks cleanly into the next. An AI that isn't guided by an expert produces confident nonsense. An expert who's disconnected from your eQMS gives advice that never makes it into the file. An eQMS that doesn't reflect your real regulatory pathway is just a filing cabinet. Break any joint in the chain and the innovation doesn't reach the patient.

Most of the wasted time in medtech regulation lives in those broken joints. A consultant who isn't plugged into your quality system. An eQMS that doesn't match the strategy you're actually pursuing. A regulatory plan that shifts while nothing else updates. Every gap adds a detour. Rework, re-submission, a delayed audit, an avoidable rejection. Dovetail closes the gaps, and that is what keeps your path to market from getting longer than it needs to be.

Why "fit" matters more in medtech than almost anywhere else

In most industries, product-market fit is the finish line. In medtech, it's only the beginning.

Your device can be brilliant and still go nowhere. You also need clinical evidence, risk management, bio-compatibility data, human-factors validation, cybersecurity controls, defensible claims, a quality system, the right regulatory pathway, technical documentation, post-market surveillance, and market access, and all of it has to lock together. If any one of those is misaligned, the whole thing stalls (or worse), no matter how good the underlying product is. Call it regulatory-market fit, the harder, higher-stakes version of the problem every founder thinks they've already solved.

Anyone who's lived through a failed submission or a rejected claim feels this in their stomach. The name is for them. It doesn't promise to make medtech simple, because it isn't. It promises to get the complex fit right.

The shortest path

There's a second thread in how we talk about the work, and it's worth naming because it sits underneath this rebrand.

What we offer founders is a shorter, cleaner path to approval. Not by rushing a safety-critical process, which would be reckless, but by knowing the terrain well enough to skip the detours and dead ends. An experienced regulatory lead walking into an audit doesn't overshare, doesn't invite questions they can't answer, and knows exactly what the auditor wants to see and how. That knowledge removes the wasted steps. It tells you where you're going, and what unnecessary suffering looks like so you can avoid it. That's why we say we're the shortest path to medical device approval.

Dovetail is why that promise holds up. The path gets shorter precisely because everything locks together, the expert, the AI, the quality system, the regulatory strategy. The destination is approval, delivered as compliance-as-a-service. Dovetail is the architecture that gets you there.

What this means for you

If you're a founder, the service you'd work with, previously VCRO, is now Envoy. Same model as before. A senior regulatory team, named leads in the US, EU and Asia, embedded into yours and accountable for getting you from pre-market to clearance. Superpowered by our AI agent so it costs less and moves faster than hiring a Chief Regulatory Officer you can't yet justify.

The name carries the whole idea. An envoy is someone you send to act and negotiate on your behalf, the one who walks into the FDA pre-sub, the notified-body review and the audit, and handles the back-and-forth so you don't have to. That's the shift the name makes, from advisor to representative. You don't have to become a regulatory expert or stand up a team of your own. You send an Envoy. And you don't send a junior, you send someone senior, trusted, and empowered to make the call in the room. The Envoy represents you.

If you run a regulatory team, nothing changes in your day-to-day. The AI agent and eQMS you already know and love are now Dovetail QMS Plus. Same platform, same data, same migration-friendly approach in and out.

If you're somewhere in between, you can take us on as your full team or use the platform yourself. That was true as Formly and it's true as Dovetail.

The practical details

• From now on we'll be Dovetail. You'll see it roll out across our site, product and communications.
• If you're a customer, your account, data and contracts are unaffected. Nothing on your side needs to move.
• Security stays exactly as it was. Your IP, design files and trade secrets stay protected by full NDAs, ISO 27001-aligned security and comprehensive contracts. You retain complete ownership of everything you bring to us.
• Links and logins keep working as usual through the transition. If you ever need to act on something, we'll tell you well ahead of time.

The work is the same work it's always been. Getting safe, important devices to the people who need them, without the years of avoidable detours. We just have a name that finally describes how we do it.

If your device is on that path, the best next step is the same as it's always been. Book a 30-minute discovery call and we'll tell you honestly whether we can help, and if so, what your route to market actually looks like.

Want to map your pathway first? Start free.

Not sure where to start your regulatory journey? We run two free programs for startups who want to know exactly what their path to market looks like, and get off to a good footing with the regulatory powers that be.

For Europe, the MDR Pathway and Notified Body Match program gives you a pathway assessment, matches you to the right notified body, and we set up, and attend the intro meeting with you. Apply for the MDR program here.

For the US, the FDA Pathway and Pre-Submission Meeting program prepares you for your FDA Pre-Submission meeting, and we attend the meeting with you to make sure you get off to a good start. Apply for the FDA program here.

Both are free, and we only take on three founders a month for each program.

Formly is now Dovetail. The regulatory partner for medtech companies who want to take the shortest path to approval. Embedded senior experts, AI agents trained on live regulation, and an eQMS built by the people who use it. Visit withdovetail.com to learn more.