FormlyAI

What FormlyAI does

Dovetail, formerly FormlyAI Inc., is an AI-powered regulatory compliance platform purpose-built for medical device companies. Founded in 2021 and headquartered in Charleston, US, the company addresses the slow, manual, and error-prone nature of medtech regulatory submissions by combining three integrated offerings: Dovetail QMS Plus (an ISO 13485-aligned Quality Management System that creates audit-ready documents), Dovetail Envoy (an embedded senior regulatory leadership service staffed by ex-FDA experts and specialists across FDA, EU MDR, EU IVDR, UKCA, and MDSAP jurisdictions), and a domain-specialized AI Agent that drafts, checks, explains, and retrieves live regulatory sources. The AI agent operates in-browser or via an MCP server that integrates inside Claude, ChatGPT, and customer tool stacks.

The company operates a hybrid platform-plus-services model serving two primary segments: medtech startups needing senior regulatory leadership without the cost of a full-time CRO hire, and established regulatory teams, RA consultants, and product teams running compliance themselves. GTM combines enterprise field sales (discovery call-first for Envoy engagements), sales-led motions with named in-country leads across US, EU, and Asia, and product-led self-serve access for QMS Plus. Revenue is generated through recurring SaaS subscriptions for QMS Plus, subscription-based embedded team retainers for Envoy, and professional services bundled into Envoy engagements. Pricing is not publicly disclosed and is set per engagement based on team size and stage.

Dovetail holds SOC 2 Type II certification, maintains ISO 27001-aligned security practices, and is GDPR compliant, with enterprise-grade data protection articulated via a public Trust Centre. The company has secured strategic partnerships with MedTech Innovator and ABHI, and counts Heal Capital (lead), Gradient Ventures, Gaingels, Mana Ventures, and Massive Tech Ventures among its investor network following a $2M seed round in September 2025.

Name

FormlyAI

Legal name

FormlyAI Inc.

Website

https://formly.ai

Company type

Private

Founded year

2021

Operating status

Operating

Headcount range

11–50 employees

Short description

Dovetail (formerly FormlyAI) is an AI-powered regulatory compliance platform for medical device companies, combining a domain-specialized AI agent, an ISO 13485-aligned QMS, and embedded ex-FDA regulatory experts to streamline FDA, EU MDR, UKCA, and MDSAP submissions for startups and established RA teams.

Ownership category

akta.pro rank

Product category

Medical Device Regulatory Compliance Software

NAICS

Telephone Call Centers (56142)

SIC

Services-Computer Programming, Data Processing, Etc. (7370)

akta.pro primary industry

AI Integration & Orchestration Platforms (Connectors, Workflow, iPaaS for AI) (HDAEANAI)

Keywords

• Medical device compliance
• Regulatory affairs software
• Quality management system
• AI regulatory agent
• FDA submission platform

Headquarters

HQ city

Charleston

HQ country

United States

HQ region

North America

Offices3 records

Markets served

GTM type

B2B

Offering type

Software

Cost components

Personnel, Technology or R&D, Operations, Marketing or Sales, Infrastructure, Others

Revenue model

1. Dovetail QMS Plus Subscription: SaaS subscription for Quality Management System with AI agent capabilities. Designed for regulatory teams running compliance themselves. Pricing varies by team size and stage.
2. Dovetail Envoy (Embedded Regulatory Team): Full-service regulatory team embedding into client organizations. Provides senior regulatory leadership without requiring a full-time CRO hire. Combines expert consultants with AI agent technology for cost efficiency.
3. Professional Services: Regulatory submission handling and advisory services. Senior ex-FDA experts who handle submissions, not just advise on them. Included as part of Envoy team service.

Go-to-market motion3 records

Distribution channels3 records

Marketing channels7 records

Core offering

FormlyAI (now Dovetail) provides an AI-powered regulatory compliance platform for medical device companies, combining the Dovetail AI Agent, the ISO 13485-aligned QMS Plus quality management system, and the Dovetail Envoy embedded regulatory team of senior ex-FDA experts. Customers can either engage Dovetail as a full-service regulatory team or self-serve through the QMS Plus platform and AI agent, with the AI agent accessible via browser or through an MCP server inside Claude, ChatGPT and existing tools. Coverage spans FDA, EU MDR, EU IVDR, UKCA, ISO 13485 and MDSAP submissions and ongoing compliance.

Product overview

Dovetail (formerly FormlyAI) is a regulatory compliance platform for medtech companies, offering a platform-plus-services architecture. The core portfolio consists of Dovetail QMS Plus (quality management system), Dovetail Envoy (embedded regulatory team service), and Dovetail AI Agent (AI-powered regulatory assistant). Companies can engage as either full-service clients with Envoy, or self-service users of QMS Plus and AI Agent, with the AI agent accessible via browser or MCP server integration. The platform serves both early-stage startups needing regulatory leadership and established teams running compliance independently.

Differentiator

Problem solved

Functional benefit

Brands

• Dovetail QMS Plus: AI-powered Quality Management System for regulatory compliance, ISO 13485-aligned, audit-ready document creation platform.
• Dovetail Envoy
• Dovetail Agents

Products and services

• Dovetail QMS Plus ISO 13485-aligned Quality Management System that creates documents rather than just storing them; audit-ready and migration-friendly. Designed for RA consultants, in-house regulatory teams and product teams running compliance themselves.
• Dovetail Envoy Embedded senior regulatory leadership service providing ex-FDA experts and specialists across MDR, FDA, UKCA and MDSAP, with named in-country leads in the US, EU and Asia. Targets medtech startups needing a full regulatory team from pre-market through clearance, supercharged by the AI agent for cost and time efficiency.
• Dovetail AI Agent AI agent trained specifically on medical device regulation that drafts, checks, explains and searches live regulatory sources. Accessible via browser or integrated inside Claude, ChatGPT and existing tools through an MCP server, handling tedious regulatory research and drafting tasks.
• Dovetail Regulatory Compliance Platform Unified regulatory compliance platform for medical device companies that bundles QMS Plus, the AI Agent and the Envoy embedded team into a single offering. Supports either full-service engagement (Envoy) or self-service (QMS Plus and AI Agent) across multiple global regulatory frameworks.

Quantifiable outcome

• Saves 3-5 years of regulatory timeline according to customer testimonial

Named customers1 record

Segments2 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

Yes

API docs

API detail

Core technology

AI maturity

App detail

Integration2 records

AI capability5 records

Feature4 records

Partnerships

Three partnerships are on record, tiered core and minor.

• MedTech InnovatorcoreStrategic or Co-development PartnerMedTech Innovator accelerator partnership. Dovetail works closely with leading medtech accelerators as part of their ecosystem approach to reaching startups early in their regulatory journey.
• ABHI (Association of British Health-Tech Industries)coreStrategic or Co-development PartnerPartnership with UK health-tech industry association for market access and industry representation. Supports Dovetail's global market access strategy and UKCA certification offerings.
• Silicon AlleeminorStrategic or Co-development PartnerBerlin-based tech community and startup network. Listed as part of Dovetail's partner ecosystem, potentially supporting European market presence.

Scale indicators1 record

Recent moves7 records

Expansion highlights6 records

Direct peers

• Greenlight Guru: Greenlight Guru is a QMS and regulatory platform purpose-built for medical device companies, offering ISO 13485-aligned document control, design controls, and submission workflows. It directly overlaps Dovetail's QMS Plus and serves the same medtech regulatory buyer.
• Qualio: Qualio provides a cloud QMS for life sciences and medtech companies, with document management, training, and audit-readiness features. It competes with Dovetail QMS Plus for the in-house regulatory team buyer and is now layering AI capabilities.
• Dot Compliance: Dot Compliance offers an AI-powered QMS built on Salesforce for life sciences, with strong document generation and compliance workflow automation. It is a close direct peer given its AI-first positioning for regulated submissions.
• ComplianceQuest: ComplianceQuest is a cloud-native QMS and EQMS platform built on Salesforce for regulated industries, including medical devices and life sciences. It is a direct peer to QMS Plus in the AI-enabled QMS space.

Broad incumbents

• MasterControl: MasterControl is a long-established QMS and quality management platform serving regulated industries including medical devices. It is a broad incumbent in the same category Dovetail targets, with a much larger install base and broader portfolio.
• Veeva Vault Quality: Veeva Vault provides regulated quality, clinical, and regulatory content management for life sciences, including medical device manufacturers. It is a broad incumbent with overlapping capabilities to QMS Plus and far greater enterprise scale.
• ETQ (Hexagon): ETQ, part of Hexagon, provides enterprise QMS for regulated manufacturers including medical devices, with broad document, audit, and compliance capabilities. It is a broad incumbent adjacent to Dovetail's QMS Plus target buyer.
• IQVIA Regulatory: IQVIA is the largest CRO and regulatory services provider for life sciences, including medical device regulatory submissions and consulting. It competes with the Envoy embedded-team model at the high end of the market with far greater scale.

Emerging players

• RegASK: RegASK is an AI-driven regulatory intelligence and workflow platform that helps life sciences companies monitor regulations and manage submissions. It is an emerging player with strong overlap on the AI-regulatory-research side of Dovetail's offering.

Others

• Charles River Laboratories: Charles River Laboratories is a major CRO offering regulatory and submission support services to medical device and pharma companies. It is a broad incumbent services peer rather than a technology competitor, but addresses the same regulatory-submissions buyer as Dovetail Envoy.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks5 records

Key highlights7 records

Customer concentration

• Xx.com/withdovetail
• YouTubeyoutube.com/@withdovetail
• LinkedInlinkedin.com/company/formlyai

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Funding overview

Funding rounds1 record

Investors5 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about FormlyAI