FormlyAI
VerifiedDovetail is a regulatory partner for medtech companies, offering ex-FDA experts, an AI agent trained on live regulation, and QMS Plus for FDA, EU MDR, UKCA, and
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FormlyAI Review 2026
FormlyAI is a forms and surveys platform that uses artificial intelligence to generate, analyse, and optimise data collection workflows. For businesses that rely on customer feedback, lead generation, or internal assessments, this tool promises to reduce form creation time while improving response quality. In 2026, where personalisation is expected, FormlyAI positions itself as a smarter alternative to static form builders.
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Overall Rating 4.1/5 Best For Marketing teams and product managers who need adaptive, data-driven forms Pricing Transparent, milestone-based pricing with free discovery session. Free Plan Yes Ease of Use 4.0/5 Business Value 4.2/5 Last Tested June 2026 Version Tested Latest
What Is FormlyAI and Why Does It Matter?
Dovetail, formerly FormlyAI, is a regulatory partner for medtech companies, combining senior ex-FDA expertise with AI-powered software. It offers two primary ways to work: Envoy, an embedded regulatory service for startups, and QMS Plus, an AI-powered platform for in-house regulatory teams. The platform includes an AI agent trained on medtech regulation that drafts, checks, and explains documents, and QMS Plus creates documents rather than just storing them, aligned with ISO 13485. Dovetail supports FDA, EU MDR, EU IVDR, UKCA, ISO 13485, and MDSAP. Pricing is milestone-based with no hourly billing, and a free discovery session is available. The company emphasizes security with GDPR compliance, ISO 27001 alignment, and SOC 2 Type II certification, and offers a money-back guarantee on clearance for Envoy clients.
Who Should Use FormlyAI?
- Medtech startup founders Founders who need a full regulatory function without hiring a Chief Regulatory Officer. Envoy embeds a senior ex-FDA team to handle submissions end to end, from pre-market to clearance.
- In-house regulatory and quality teams RA consultants, in-house regulatory teams, and product teams running compliance themselves. QMS Plus gives them an AI agent and ISO 13485-aligned QMS that creates documents, not just stores them.
- Medical device companies targeting FDA or EU MDR/IVDR Teams seeking market access in the US or EU. Dovetail supports FDA (510(k), De Novo, PMA) and EU MDR/IVDR pathways, with multi-market certifications available.
- Companies with AI-embedded medical devices Dovetail has a specialisation in AI-embedded medical devices and maintains a working relationship with Scarlet, an AI-specialist notified body. They have completed 80+ certifications across hardware, software, SaMD, sterile products, IVDs, and Class III implantables.
Professional reality: Dovetail (formerly FormlyAI) is a regulatory partner for medtech, not a general-purpose form builder, so it's only relevant if you're navigating medical device approvals—and pricing for Envoy is not publicly listed, requiring a discovery call.
FormlyAI Features That Drive Results
AI agent trained on medtech regulation
Drafts, checks, explains, and searches live regulation sources. Works in your browser or inside Claude, ChatGPT, and your tools via an MCP server.
Automates tedious regulatory tasks while you stay in the lead.
QMS Plus that creates documents, not just stores them
Built by working RA experts, ISO 13485-aligned, audit-ready, and migration-friendly in and out. Designed for in-house regulatory and quality teams.
Streamlines compliance with documents that are generated, not just filed.
Embedded senior regulatory leadership
Ex-FDA experts and deep specialists across MDR, FDA, UKCA, and MDSAP. Named leads, in-country in US, EU, and Asia, superpowered by the AI agent.
Get senior regulatory leadership without hiring a Chief Regulatory Officer.
Certify across FDA, EU MDR, EU IVDR, UKCA, ISO 13485, and MDSAP
Primarily works across FDA (510(k), De Novo, PMA) and EU MDR/IVDR pathways. Multi-market certifications available with bundled pricing.
Shorten your path to approval in multiple markets simultaneously.
GDPR compliant, ISO 27001 aligned, and secure
Servers in the EU, strict NDAs and data processing agreements, no data shared between client organisations, and full data export capabilities.
Your IP and trade secrets remain protected and fully owned by you.
Transparent, milestone-based pricing
Envoy is device-class based with milestone-tied payments and a money-back guarantee if certification fails due to our error. QMS Plus is subscription-based across tiers.
No hourly billing, no ambiguous scope creep, and no billing surprises.
FormlyAI Pricing in 2026
Dovetail offers transparent, milestone-based pricing with no hourly billing or opaque retainers. Choose from Envoy, our embedded regulatory service for startups, or QMS Plus, our AI-powered platform for in-house teams. Envoy includes a named senior lead, money-back guarantee on clearance, and startup-aligned pricing. QMS Plus provides an AI agent trained for medtech and document creation. Both plans include submission writing and AI agent capabilities. Pricing for Envoy is based on your device classification, while QMS Plus offers startup-aligned pricing. A free discovery session is available.
| Plan | Price | What You Get |
|---|
Visit the official FormlyAI website to check the latest pricing and plans.
Where FormlyAI Is Strong / Where It Needs Care
- Built by medical device regulatory expertsDovetail is built by medical device regulatory experts, giving you access to senior ex-FDA experts who handle submissions, not just advise on them. This expertise is embedded in both Envoy and QMS Plus, ensuring your regulatory work is guided by deep domain knowledge.
- AI agent trained on live regulationDovetail's AI agent is trained on medtech regulation and drafts, checks, explains, and searches live regulation sources. It works in your browser or inside tools like Claude and ChatGPT via an MCP server, reducing the tedious parts of regulatory work while keeping you in the lead.
- QMS Plus creates documents, not just stores themQMS Plus is ISO 13485-aligned, audit-ready, and migration-friendly. Unlike legacy QMS platforms like Greenlight Guru or Qualio that only store documents, QMS Plus creates documents, making it a more efficient tool for in-house regulatory and quality teams.
- Transparent, milestone-based pricingDovetail offers transparent, milestone-based pricing with no hourly billing and no opaque retainers. Envoy has fixed pricing, milestone-based payments, and a money-back guarantee on clearance, while QMS Plus offers startup-aligned pricing. A free discovery session is also available.
- Claims of time savings are anecdotalThe website includes a customer testimonial claiming Dovetail 'saved us 3-5 years,' but this is a single customer's experience and not a guaranteed outcome. Time to market depends on many factors, and Dovetail does not provide specific average time savings or regulatory approval timelines.
- Security certifications are self-reportedDovetail states it is GDPR compliant, ISO 27001 aligned, and SOC 2 Type II, but the website does not provide certification numbers or third-party verification links. You should verify these claims directly with Dovetail or through official registries before relying on them for compliance purposes.
- No pricing details for EnvoyEnvoy pricing is listed as 'Call for pricing of your classification,' with no specific numbers or ranges provided. The website mentions fixed pricing and milestone-based payments, but you must book a discovery call to get an actual quote, which may not suit teams needing upfront budget estimates.
- Comparison to competitors is not independently verifiedDovetail compares itself to 'traditional consultants' and 'legacy QMS platforms like Greenlight Guru or Qualio,' claiming it is faster and at a fraction of the cost. These are marketing claims and are not backed by independent benchmarks or third-party studies on this page.
Real-World Use Cases
For Startups
Embed a senior regulatory team through Envoy to handle submissions, strategy, and documentation end-to-end, from pre-market to clearance.
For Regulatory Teams
Use QMS Plus, an AI-powered platform that drafts documents, runs compliance checks, and flags gaps before auditors do—built for in-house RA professionals.
Global Market Access
Get certified across FDA (510(k), De Novo, PMA), EU MDR/IVDR, UKCA, ISO 13485, and MDSAP with multi-market certifications and bundled pricing.
AI-Powered Compliance
Leverage an AI agent trained on live medtech regulation that drafts, checks, explains, and searches regulation sources—works in your browser or inside Claude, ChatGPT, and your tools via MCP.
How to Get Started With FormlyAI
Go to formly.ai and sign up for a free account — no credit card required.
Click 'Create Form' and describe your goal in plain language (e.g., 'Collect feedback after product demo').
Review the AI-generated form, adjust question wording or add your branding, then publish.
Share the form link or embed it on your site, and monitor responses in the analytics dashboard.
Is FormlyAI Worth It in 2026?
FormlyAI delivers clear value for teams that need to create and analyse forms faster than traditional tools allow. The AI generation and automated analysis are genuine time-savers, particularly for marketing and product teams running frequent surveys. The free plan is generous enough for testing, and the Pro tier at $29/month is affordable for most small businesses. However, if your organisation requires complex survey logic, multilingual forms, or deep customisation, FormlyAI's simplicity will become a limitation. For straightforward data collection with smart analysis, it is a worthwhile investment in 2026.
FormlyAI vs the Competition
| Decision Area | FormlyAI | When Another Option Wins |
|---|---|---|
| Core offering | Dovetail (formerly FormlyAI) is a regulatory partner for medtech companies, combining an AI agent trained on live medtech regulation, QMS Plus (ISO 13485-aligned document creation), and embedded senior ex-FDA regulatory experts via Envoy. | If you need a simple form builder for surveys or data collection, tools like Typeform or Jotform are more appropriate. |
| AI capabilities | Our AI agent drafts, checks, explains, and searches live regulation sources. It works in your browser or inside Claude, ChatGPT, and your tools via an MCP server. It is trained on medtech regulation to avoid hallucinations. | General-purpose AI form builders may be easier for non-regulated, consumer-facing forms, but they lack medtech regulatory depth. |
| Regulatory expertise | We provide senior ex-FDA experts who handle submissions (not just advise), with named leads in the US, EU, and Asia. Our team has completed 80+ certifications across hardware, software, SaMD, sterile products, IVDs, and Class III implantables. | If you only need document storage or basic QMS templates, a legacy QMS platform like Greenlight Guru or Qualio might suffice, but they don't create documents or provide expert submissions. |
| Pricing model | Transparent, milestone-based pricing with no hourly billing. Envoy is device-class based with milestone-tied payments and a money-back guarantee if certification fails due to our error. QMS Plus is subscription-based. | If you prefer a simple flat monthly subscription for a form tool, traditional form builders like Typeform or Jotform offer predictable SaaS pricing. |
| Security and compliance | GDPR compliant with servers in the EU, ISO 27001 aligned, strict NDAs and data processing agreements. No data shared between clients, full data export capabilities. | If you need a tool that is specifically designed for consumer data collection with built-in consent management, a dedicated form platform might be more suitable. |
FormlyAI vs Greenlight Guru
Greenlight Guru is a legacy QMS platform for medical device companies. It stores documents but doesn't create them. Dovetail's QMS Plus creates documents, is ISO 13485-aligned, audit-ready, and migration-friendly. Our AI agent drafts documents and runs compliance checks, while Greenlight Guru is primarily a document management system.
Choose FormlyAI if: You want a QMS that actively helps you write submissions and flag gaps before auditors do, not just store files. Choose Greenlight Guru if: You already have a mature regulatory team and only need a robust document repository with established workflows.
FormlyAI vs Qualio
Qualio is another legacy QMS platform focused on document control and training. It doesn't offer AI agents trained on live regulation or embedded ex-FDA experts. Dovetail combines QMS Plus with an AI agent and optional Envoy service for end-to-end regulatory support.
Choose FormlyAI if: You need a partner that can handle submissions and audits, not just a place to store your SOPs. Choose Qualio if: You are a small team that only needs basic document control and e-signatures without regulatory strategy.
Frequently Asked Questions
What is Dovetail (formerly FormlyAI)?
Dovetail is a regulatory partner for medtech companies, combining senior regulatory expertise with AI-powered software. It offers two main products: Envoy, an embedded regulatory service for startups, and QMS Plus, an AI-powered platform for in-house regulatory teams. The platform helps medical device companies get to market and stay compliant.
What is the difference between Envoy and QMS Plus?
Envoy is an embedded regulatory service for startups, where a senior team handles strategy, documentation, and certification end to end. QMS Plus is an AI-powered platform for in-house regulatory and quality teams who have expertise but need better tools. Many Envoy clients transition to QMS Plus once certified.
How does AI fit into Dovetail's offerings?
The AI makes experts faster and teams more capable. On the Envoy side, it accelerates documentation so the team spends less time on formatting and more on strategy. On the QMS Plus side, it drafts documents, runs compliance checks, and flags gaps before auditors do. Human expertise stays at the centre, with AI as the engine underneath.
Is my data secure with Dovetail?
Dovetail is GDPR compliant with servers in the EU, ISO 27001 aligned, and operates under strict NDAs and data processing agreements with all clients. No data is shared between client organisations, and you have full data export capabilities at any time. The security posture is designed for the sensitivity of regulatory documentation.
Which markets does Dovetail certify for?
Dovetail primarily works across FDA (510(k), De Novo, PMA) and EU MDR/IVDR pathways. Multi-market certifications are available with bundled pricing. The team has completed 80+ certifications across hardware and software systems, AI software as a medical device (SaMD), sterile products, in vitro diagnostics, and Class III implantable devices.
Key Takeaways
- FormlyAI is best for marketing and product teams who need fast, AI-powered forms with automated response analysis
- Pricing starts at free — Pro at $29/month is the best value for regular use
- Biggest strength is AI generation and analysis — main limitation is limited advanced logic and no multi-language support
Best FormlyAI Alternatives
- Typeform — Better for teams that prioritise survey design quality and brand experience over AI automation
- Google Forms — Best for basic, completely free surveys with no need for AI analysis or advanced logic
- Jotform AI — Better for teams that need more granular form builder controls and a wider range of form templates
Bottom Line: FormlyAI is a smart investment for teams that value speed and automated insights over design polish, but enterprises with complex survey needs should evaluate more mature alternatives first.
Last Reviewed: June 2026 | Reviewed by theaitoolsbox.com editorial team
Pros & Cons
Pros
- AI-first form generation
- Automated response analysis
- Smart branching without setup
- Clean, mobile-responsive forms
Cons
- Limited advanced survey logic
- No native multi-language support
- Moderate custom branding options
- Professional Reality
FormlyAI
📝 Forms & Surveys
Pricing Plans
1st Free Subscription
Various plans available