How do you get a clinical AI product through conformity assessment when its outputs aren’t fully predictable and its next version is already in development? Navigating the EU MDR and AI Act means working out how to evaluate that variability, demonstrate performance and manage continued change. Dovetail and IDM
Dovetail Coworker is now available in Slack and Teams. Regulatory help where your team works, with experts responsible for judgment and review.
Keep medtech training tied to current document revisions. QMS Plus uses your group mappings to assign work and keep signed records with the relevant revision.
Compliance tools are growing by the dozens but they can't solve your key strategy questions or talk to auditors for you just yet. Understand each tools limitations, and position them tools alongside an expert strategically to get the most out of them.
Choose the right clinical evidence approach and you can build a plan that satisfies the EU, UK, and US regulatory requirements all at once.
A founder's guide to European investors funding medtech in 2026, what they back, and what they want to see before they write the cheque.
At Dovetail, we believe in human judgement alongside brilliant AI. AI has brought unbridled efficiency to our work and intelligence to our fingertips that was previously inaccessible. You could have it build any document with the right context. It’s enough to do just about anything. But not everything. It
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.
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
