An AI agent trained on medtech regulation and QMS Plus, built by working RA experts who got tired of the tools available to them. ISO 13485 validated. Generates compliant documents for you, connects to the tools you already use, and keeps you audit ready.
Companies across markets trust Dovetail with their most complex, life-saving medical devices.
Whether you're a consultant managing multiple clients, a product team running compliance alongside development, or a director overseeing a portfolio, Dovetail replaces the tools that slow you down.
Compliance that fits inside your existing workflow, rather than sitting outside it waiting to slow you down. Change management, ongoing compliance and direct integration with your development tools.
Quality-first document drafting and review, with a full audit trail for every edit. GDPR-compliant, transparent and built to meet the standard of scrutiny your clients will face.
Portfolio-wide document management with standardised processes and global search across all your products. The visibility you need without the administrative overhead that usually comes with it.
A new generation of regulation software. Try it for free.
Trained on MDR, FDA, UKCA, MDSAP, and ISO 13485. Connected to live regulation sources so it's never out of date. It does the work, you verify it.
Works where you work. In the browser, or through our MCP server inside ChatGPT, Claude, and your custom agent.
Predicate search (FDA)
Device classification across jurisdictions
Document drafting and review
Gap analysis against ISO, MDR, FDA standards
Submission format checker
Made for teamwork
Not another document store. It creates documents, connects to your design files, captures change control properly, and links every piece of evidence back to the standard it satisfies. Built by our ex-FDA RA expert team, for working RA teams.
Document control (ISO 13485-aligned)
Design file and DHF management
CAPA, complaint, and nonconformity workflows
Audit trail and e-sign
Port-out on exit, no lock-in
Migration in from Greenlight Guru, Qualio, Arena or any other QMS
Most platforms tell you what to do and leave you to do it. Dovetail does it with you.
Whether you're evaluating the platform or running a full regulatory programme, there's a plan designed for your team size and stage.
€0
Put it to work on a real project, not a sandbox. Bring an active case, run it through the platform and see what your regulatory workflow looks like when the tools actually work.
WHAT'S INCLUDEDNo credit card required
No obligations or pressure
Try before you buy
Product support
€300/m
Connect to the tools your team already use and run your quality management the way it should always have been. QMS Plus fits around your workflow.
WHAT'S INCLUDEDFirst month free
Product support
No lock-in contract
Dedicated account manager
Configured to your specific environment and scaled across your largest teams, with the customisation that makes adoption stick across a complex organisation.
WHAT'S INCLUDEDCustom implementation
Dedicated account manager
Top tier support
Dovetail QMS Plus gives you the tools to run compliance independently. But if you're navigating a new market, a new device class, or a submission you'd rather not own alone, Envoy puts a senior regulatory team in your corner. Same platform, with us doing the heavy lifting.
Some of the questions we hear most often. If yours isn't here, get in touch and we'll answer it directly.
Most QMS platforms are document libraries with a workflow layer on top. Dovetail creates documents: tech file sections, risk assessments, SOPs, clinical evaluations, built using AI trained on regulatory requirements and developed by working RA professionals. The difference isn't marginal. Teams that switch from Greenlight Guru or Qualio typically cut documentation time significantly and stop dreading audit season.
Most teams are up and running within a week. If you're migrating from an existing QMS, we provide migration support and the timeline depends on your current system and documentation quality. We do a gap analysis upfront so there are no surprises. You won't spend months configuring the platform before it's useful.
Yes. We include a gap analysis to assess your existing documentation and build migration support into onboarding. Where your existing work meets quality standards, we build on it rather than asking you to start from scratch. And when you leave, if you ever do, you take everything with you. Full export, always.
QMS Plus exports to PDF, Word, and Google Docs with preserved formatting, and integrates with Jira, Confluence, and GitHub. Unlimited user seats are standard across all tiers. API access is available for teams with custom integration requirements. If you have a specific integration need, ask us.
The AI cross-references your documentation against the relevant standard in real time, whether that's ISO 13485, MDR Annex I, FDA 21 CFR Part 820, or others. It flags gaps, inconsistencies, and missing evidence before a notified body or auditor does. It doesn't make decisions for you, but it makes sure you're not surprised by anything you could have caught earlier.
All tiers include unlimited user seats. Regulatory work involves more people than just the RA function: product leads, clinical teams, quality, engineering. Everyone who touches a document should be in the platform, and we don't charge extra to make that possible.
QMS Plus is built around ISO 13485, EU MDR, EU IVDR, FDA 21 CFR Part 820/830, and IEC 62304 for software. If your device involves AI or ML components, we have dedicated support for SaMD documentation requirements, including IMDRF guidance alignment and EU AI Act considerations where they intersect with MDR.
Pricing is subscription-based across three tiers: Core, Pro, and Enterprise, designed for teams at different stages of growth. All tiers include unlimited users. Enterprise adds custom implementation, SSO, dedicated support, and advanced API access. We don't use per-seat pricing because that creates the wrong incentives. Get in touch if your situation needs a tailored quote.
We're GDPR compliant with servers in the EU, ISO 27001 aligned, and operate under data processing agreements with all clients. No data is shared between organisations, and you retain full export rights at any time. Our security documentation is available on request if you're running a procurement process.
That's where it earns its keep. Every document has a full audit trail: version history, approvals, timestamps, links to supporting evidence. Your technical file is structured to match notified body review expectations. Our team has been on both sides of a lot of audits, and the platform reflects that. Pre-audit reviews are available if you want a second set of eyes before a major submission.
Your IP, design files and trade secrets are protected by full NDAs, ISO 27001-aligned security and comprehensive contracts, so you retain complete ownership of everything you bring to us.
Visit our Trust CentreThe best way to evaluate a regulatory platform is to put real work through it. Start a 30-day trial and run one of your active projects through Dovetail. If it doesn't work for you, walk away with no strings attached.
