You can't improve lives if you don't get to market

Dovetail is a regulatory partner for medtech companies: not a traditional consultancy, not just another QMS platform. We combine senior regulatory expertise with AI-powered software to help medical device companies get to market and stay compliant. Depending on where you are, that might mean embedding a regulatory team into your startup through Envoy, or giving your in-house RA team the platform they actually want to use.

Envoy is our embedded regulatory service for startups. A senior team handles your strategy, documentation, and certification end to end so you can focus on building. The QMS Plus is our AI-powered platform for in-house regulatory and quality teams who have the expertise but need better tools. Many Envoy clients transition to QMS Plus once certified.

We work with two types of medtech teams. Founders who need a full regulatory function without the hire: Envoy was built for you. And in-house RA professionals who are tired of systems that store documents instead of creating them: the QMS Plus was built for you. If you're building a medical device and regulation is the blocker, you're probably in the right place.

The AI makes our experts faster and your team more capable; it doesn't replace either. On the Envoy side, it accelerates documentation so our team spends less time on formatting and more on strategy. On the QMS Plus side, it drafts documents, runs compliance checks, and flags gaps before auditors do. Human expertise stays at the centre, with the AI as the engine underneath.

We're GDPR compliant with servers in the EU, ISO 27001 aligned, and we operate under strict NDAs and data processing agreements with all clients. No data is shared between client organisations, and you have full data export capabilities at any time. Our security posture is designed specifically for the sensitivity of regulatory documentation.

Traditional consultants are expensive, slow, and leave when the project ends. Legacy QMS platforms like Greenlight Guru or Qualio store your documents but don't create them. Dovetail does both, faster, at a fraction of the cost, and without vendor lock-in. Our fixed-fee model means no billing surprises, and our no lock-in policy means you can export everything you've ever created.

We primarily work across FDA (510(k), De Novo, PMA) and EU MDR/IVDR pathways. Multi-market certifications are available and come with bundled pricing. If you're weighing which market to enter first, that's one of the first conversations we'll have together.

Our team has completed 80+ certifications across hardware and software systems, AI software as a medical device (SaMD), sterile products, in vitro diagnostics, Class III implantable devices, and more. We've developed a specialisation in AI-embedded medical devices and maintain a working relationship with Scarlet, an AI-specialist notified body.

Pricing depends on your product. Envoy is device-class based with milestone-tied payments, so you're not funding work you haven't seen yet. Multi-market certifications come with discounts, and we offer a money-back guarantee if certification fails because of our error. QMS Plus pricing is subscription-based across tiers built for different team sizes. No hourly billing, no ambiguous scope creep.

If you're not sure which product fits your situation, start with a discovery call. We'll ask about your device, your team, your timeline, and your market ambitions, then recommend the right path. There's no obligation and no sales pressure, just a straight conversation about what you need.