Introducing our new collaboration suite

Why we built it from the ground up

When we work with our clients on their compliance documentation, we work through every little detail with them. The tools you need to do this while staying highly efficient are, by today's standards, quite straightforward. A world class agent that can compile information and help you write, and basic document collaboration. That is because on a highly complex document you need to:

• see who edited each part
• comment on anything that's uncertain
• propose changes and explain the reasoning
• accept, reject or resolve suggestions without losing work
• keep a full audit trail of every change

"But guys, I hear you say, we already have great tools for both. Google Docs or Word for collaboration, ChatGPT or Claude as the agent". The problem is they do not work well together. If you have tried working across many iterations, or tried asking them what Lisa commented on, what edits Paul made, or a well thought out answer to the comments made by Ruth, you will find none of it possible. And that is exactly what we need in order to deliver our service FAST and at a quality that is second to none.

So what did we do?

Creating our own AI native editor

The only way around this was to build a state-of-the-art collaboration suite with our own agent deeply embedded. It solves the problem above and gives our quality and regulatory affairs specialist agent direct access to the documentation, resulting in higher quality outcomes. And it means you get AI-first document drafting and collaboration built directly into Dovetail QMS Plus, our ISO 13485 compliant quality management system.

For us this is not a nice-to-have. It is hundreds of hours of work saved, and ultimately faster outcomes for our clients and thousands of dollars and euros saved.

Why this blows our mind and will do yours too

This feature may seem small but it’s mighty. It allows you to:

• Create high quality documentation with the Dovetail agent.
• Leverage a huge library of reusable data keys that you can reuse across documents. Managed natively by the Dovetail agent.
• Define your intended use once and keep it current across your Clinical Evaluation Report, Technical File, Instructions for Use, Clinical Evaluation Plan, Periodic Safety Update Report, Post-Market Clinical Follow-up Report, EU Declaration of Conformity, to name a few.
• Trust your variables. They load dynamically across documents, so copying in and out of Google Docs would quietly break them. Here nothing moves and nothing goes stale.
• Ask our agent to review all comments and redlines on a 50 page document, give you a brief and then address all of them.
• Know what changes Paul, Lisa and Jane made in revision 1, 4 and 6 of your clinical evaluation word for word.
• Edit the same document together in real time.
• Make surgical edits on big documents with high accuracy. Tell our agent to update the requirements mapping a table in 10 documents and tag your coworker for review on it.
• Skip the copy-paste from a Google Doc to your quality management system. Write, collaborate, approve. That's it.
• And much more

What this means

The best part is this is not only available to us but for all teams working on medical device compliance in our software starting today.

Severin Högl is the CTO and co-founder of Dovetail (formerly FormlyAI), and has experienced the difficulties of medical device CE marking firsthand, building and certifying a patient monitoring app in a previous venture. Today he leads the team behind Dovetail's AI agent, building regulatory AI that's a step ahead of the generic tools everyone else is using.