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 offer a

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 Formly'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 of a $2M seed

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 they

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 if

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 funds

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

How to Keep Your Medical Device on the Market With Post-Market Surveillance

What is Post-Market Surveillance? Post-market surveillance (PMS) in medical devices is a systematic process that monitors the safety and performance of a medical device after it has been released on the market.  After your device goes to market, this ongoing process is used to identify potential safety issues, respond to

How To Choose The Right Notified Body

Most medical device companies must undergo a conformity assessment (essentially an audit) prescribed by a Notified Body in order to receive a CE marking. This process is required for all medical devices and in vitro diagnostic (IVD) devices except the lowest-risk devices (Class I and Class A, respectively).  Thus, if

What is Software of Unknown Provenance (SOUP)?

In the world of medical devices, software plays a critical role. However, not all software used in these devices is developed from scratch. Often, off-the-shelf software, or software of unknown provenance (SOUP), is integrated into the device. But what exactly is SOUP? Update: We also released a new license checker

Can I Certify as Class I First and Do Class IIA Later?

Can I Certify as Class I First and Do Class IIA Later?  We have had many clients come to us and ask any variety of the same question: “I think my device will end up being Class IIA but I want to start with it on the market as Class

The Difference Between IVDR and MDR in the EU

The Difference Between IVDR and MDR in the EU The European Union's regulatory framework for medical devices can be quite perplexing, especially for startups venturing into the healthcare sector for the first (or even 10th) time. Knowing whether your product falls under In Vitro Diagnostic Regulation (IVDR) 2107/