Dovetail

Dovetail serves medtech companies needing regulatory support for medical devices. Startups can use Envoy, an embedded senior regulatory team that handles submissions and certification end to end. In-house regulatory teams and consultants can use QMS Plus, an ISO 13485-aligned quality management platform that creates documents, alongside an AI agent trained on medtech regulation. The page states that the AI agent drafts, checks, explains, and searches live regulation sources, and that it works in a browser or inside Claude, ChatGPT, and other tools via an MCP server. Dovetail states it has completed 80+ certifications across hardware, software, SaMD, sterile products, in vitro diagnostics, and Class III implantable devices, and that it works with an AI-specialist notified body. The page also lists GDPR compliance, ISO 27001 alignment, NDAs, and full data export.

Key features

• AI agent trained on medtech regulation that drafts, checks, explains, and searches live regulation sources
• MCP server integration for use inside Claude, ChatGPT, and other tools
• QMS Plus platform that creates documents, is ISO 13485-aligned, and supports migration in and out
• Envoy embedded senior regulatory leadership with named leads in the US, EU, and Asia
• Multi-market certification support across FDA (510(k), De Novo, PMA), EU MDR/IVDR, UKCA, and MDSAP
• Data export capabilities at any time and no vendor lock-in
• GDPR compliance, EU-hosted servers, and ISO 27001 alignment

Best suited for

• Medical device startups needing a full regulatory function without hiring a Chief Regulatory Officer
• In-house regulatory affairs teams and quality teams seeking better compliance tools
• RA consultants and product teams running their own regulatory compliance
• Companies pursuing multi-market approval across FDA, EU, UK, and MDSAP
• Developers of AI-embedded medical devices and SaMD

Pricing

Pricing depends on product. Envoy is device-class based with milestone-tied payments, multi-market certifications include bundled discounts, and QMS Plus is subscription-based across tiers. The page does not state specific prices.