MedTech's European Money Map: what investors are betting on in 2026.
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.
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What Dovetail’s Envoy Service Is, Why It's Different, and Why It's Working
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
Introducing our new collaboration suite
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.
An agent that gets smarter where it counts: your device, your regulatory journey, and all of our experience.
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.
Crossing the Atlantic? Four Things Every UK Medtech Founder Must Pack Before Facing the FDA.
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.
FormlyAI is now Dovetail.
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.
The FDA Q-Submission Process: A Medtech founder’s guide to the Pre-Sub
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
The AI Never Told Me: What the FDA's Warning Letter on AI Actually Means
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
AI-first traceability that humans actually want to look at
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.
Regulatory Intelligence and Workflows, Right Where You Work: Introducing Dovetail's MCP Server
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.
Breaking into the US Medtech Market: What Founders Need to Know About the FDA.
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.
FormlyAI raises $2M led by Heal Capital to revolutionize medical device compliance using AI
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
How to Estimate Risk in Medical Devices According to ISO 14971
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
Getting Started with Medical Device Risk: An Intro to ISO 14971
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.
Why every medical device manufacturer should know their GSPRs
TL;DR (too lazy, didn’t read) Medical devices need to meet specific performance and safety requirements called GSPRs (General Safety and Performance Requirements) before they can be sold in Europe. Essentially it's like a super-detailed safety checklist that ensures medical devices are safe and work like
IEC 62304: Software development, the medical device version
TL;DR (too lazy, didn’t read) IEC 62304 is basically the rulebook for medical device software development. Whether you're creating a standalone medical app or software that's built into medical devices, this standard tells you how to do it safely and properly. The standard has
Process validation 101: Why your medical device needs to work (every single time)
TL;DR (too lazy, didn’t read) Process validation is basically making sure medical devices are manufactured consistently and safely, every time they're made. It's like having a foolproof recipe that guarantees your dish comes out perfect, except instead of a souffle, we're talking
FormlyAI and QbD Group Join Forces to Revolutionize Lifescience Technical Documentation
We are excited to announce a new partnership between FormlyAI and QbD Group, a global leader in life sciences consultancy. This collaboration marks a significant step forward in enhancing efficiency and innovation in the life sciences industry. QbD Group, renowned for their comprehensive solutions across the life sciences sector, supports
9 Common Misconceptions About Medical Device Regulations
1. Regulations are the same for all medical devices EU medical devices are categorized into 4 risk classes: Class I, Class IIa, Class IIb, and Class III. Your device designation is determined by things like invasiveness (is the device implanted?), intended purpose, duration of use, active vs. non-active (meaning
Big news - introducing our new eQMS and improved pricing
We have big news! FormlyAI now has a new eQMS! And better yet, we have new more affordable pricing. Also, we are excited to announce we have finally released our new electronic Quality Management System (eQMS) that allows you to store and approve your documentation within our Formly software. This
What Happens When Your Medical Device has an Issue - The CAPA Process
Corrective and Preventive Actions (CAPA) are how you fix issues that have been identified with your medical device. Think of it as a formal way of documenting your problem fixing process. What triggers a CAPA? Issues may come from adverse events, nonconformities, audits, customer complaints, a defective component, or if
Struggling to find funding to CE mark your medical device? These grants can help.
In the dynamic landscape of the European Union, funding can make or break success for startups at their earliest stages. Finding sources of non-dilutive or public funding like grants is especially beneficial to those trying to make ends meet. In Particular, startups often grapple with the challenge of securing
The AI Act: What does this mean really for your medical device?
Artificial intelligence (AI) is exploding right now, expanding so quickly that regulations have yet to catch up, until now. The growth trajectory of AI has only increased with time, with an expected annual growth rate of 37.3% from 2023 to 2030. The European Commission AI Act (we will call
The unique device identifier (UDI) aka the barcode for EU medical devices. Do you need one?
What is a UDI? The Unique Device Identifier (UDI) system is used for the global identification and tracing of medical devices throughout their lifecycle. Think of a UDI as a barcode - each UDI is a unique assembly of letters and numbers that adhere to a universally recognized standard used to
