The shortest path to medical device approval starts here

Everything a regulatory function does, from pre-market to certification and beyond. We develop your regulatory strategy, write your technical documentation, implement and manage your QMS, handle notified body and FDA correspondence, prepare you for audits, and provide post-certification support. You also get unlimited access to our software platform and direct access to your team via a dedicated messaging channel and regular video calls. If it's regulatory, we own it alongside you.

It depends on your device class and target market. Class I devices typically run 2 to 3 months. Class IIA/B usually lands between 6 and 12 months, factoring in notified body review periods. FDA 510(k) submissions typically take 6 to 9 months, including the 90-day FDA review window. Class III takes longer, and we'll give you a realistic timeline at discovery based on your specific device and testing requirements. One of the things that can stretch timelines is slow documentation turnaround from your side, so we build that accountability into how we work together from the start.

Pricing is based on your device class. Payment is split across milestones so you're not funding work you haven't seen yet, with a portion paid upfront to kick things off and the rest tied to defined milestones through certification. If you're certifying in multiple markets at the same time, you get a discount on the combined package. We also offer a money-back guarantee if certification fails because of our error.

There's no universal answer. It depends on your target markets, device classification, clinical data requirements, your funding runway, and your commercial timeline. Figuring this out together is one of the first things we do. We'll look at your situation and give you a clear recommendation, not a list of options with no guidance. Multi-market strategies, when they make sense, come with bundled pricing.

A consultant advises. Envoy does the work. We're not sending you a strategy document and leaving you to execute it; our team writes the documents, manages the submissions, handles the back-and-forth with regulators, and shows up when things get complicated. We're also up to 10x faster than traditional consulting firms because our experts are supported by AI that handles the time-consuming parts of documentation. And because our fee is fixed, you know exactly what this costs before you start.

The team has completed 80+ certifications across a wide range of device types: AI software as a medical device, sterile implantables, Class III devices, in vitro diagnostics, and more. Spencer Todd, our CEO, has former FDA experience and a background spanning medical device manufacturing and consulting. We have a particular specialisation in AI-embedded devices and work closely with Scarlet, a notified body with a dedicated AI medical device practice.

Yes. We begin with a gap analysis to understand what you have and what quality it's at. Where your existing work holds up, we build on it rather than starting over. Where it doesn't, we tell you early so there are no surprises down the line. Coming to us mid-process with partial documentation is completely normal.

You get a dedicated regulatory lead and direct access to the team, with no account manager in between you and the person doing your work. We communicate via a shared messaging channel and regular video calls, and you'll hear from us whenever something needs your input or sign-off. Structured milestone check-ins keep everything on track without you needing to chase us for updates.

Certification is the beginning of your compliance obligation, not the end. Post-certification, you need to maintain your QMS, manage post-market surveillance, and handle design changes or incidents as they arise. Envoy clients have the option to continue with ongoing compliance support through us, or to transition to QMS Plus and run this themselves with our software. Either way, you won't be left without a plan.

Yes, and it's one of our specialist areas. We've certified a number of AI software as a medical device (SaMD) products and are closely familiar with the IMDRF guidance on AI/ML-based SaMD, the EU AI Act's intersection with MDR, and the FDA's evolving approach to software-based devices. We also maintain a working relationship with Scarlet, a notified body with a dedicated AI medical device practice. If your device involves AI and you've been told the regulatory path is unclear, that's exactly the kind of problem we're used to solving.