product release
We built our own AI-native collaboration suite, and the conversation now includes the Dovetail agent. It reads every comment and redline in your document and acts on it, right inside your ISO 13485 quality system. A huge time saver for teams, and it's available now for all users.
product release
Dovetail's agent learns from the decisions, facts, and expert feedback in your calls and written work, not just chats. It remembers what matters, keeps getting better for you, and keeps your data private.
America turns 250 this year. For UK medtech, the US market is still the market worth crossing an ocean for. Standing at the door to the US market is the FDA, and (surprise!) it works nothing like the MHRA or a Notified Body.
Same team, same platform, new name. Our experts dovetail into your team, our platform dovetails into the tools you already use, and the device you've built reaches the people who need it most. That's why we're now Dovetail.
TL;DR A Q-Submission (most often a Pre-Sub) is a free, formal way to get FDA’s written feedback on your device and your submission plan before you file. You send a short package with specific questions, FDA responds in writing within about 75 days, and they usually
A few weeks ago, the FDA sent a warning letter to Purolea Cosmetics Lab. It's been getting a lot of attention, mostly framed as a warning shot at AI in pharmaceutical manufacturing. "FDA says AI is a liability." That kind of thing. I want to offer
Formly's new traceability matrix auto-links every requirement from User Needs through Validation, exposes that traceability graph to AI agents via MCP, and finally looks like something worth using.
Formly now has an MCP server. Connect your Formly workspace directly to Claude or GPT and run regulatory research, standards lookup, and expert review without switching tools.
Compared to other regulatory authorities across the world, the FDA’s approach to regulations and engaging with companies looking to clear their medical devices is unique. The predicate system, enforcement discretion products, and the De Novo pathway, to name a few, are regulatory concepts that are unlike most other countries.
New capital to accelerate US market expansion, scale EU operations, and further develop its AI-powered platform that has already saved clients an average of $70K and reduced time-to-market tenfold. CHARLESTON, September 11, 2025 – FormlyAI, the only AI-native solution for medical device certification, today announced the closure
TL;DR If you're building a medical device, ISO 14971 is your blueprint for making sure it’s safe, and not just “we hope it doesn’t explode” safe. It's a structured way to think through what could go wrong, how bad that would be, how
TL;DR If you're building a medical device, ISO 14971 is a necessity as it is your blueprint for safety. It’s a formal process for figuring out what could possibly go wrong (hazards and harms), so you can manage those risks before they ever reach a patient.
