Dovetail provides regulatory compliance solutions for medical device companies, offering both a managed service team and a software platform to streamline global approval processes. Their offering covers major jurisdictions such as FDA, EU MDR/IVDR, UKCA, ISO 13485, and MDSAP, reducing the time and effort required to prepare and submit documentation. By integrating secure, AI‑assisted tools with expert guidance, Dovetail helps firms accelerate market entry while protecting their IP.
Funding
Funding not disclosed
Founders
Product
Problem
Medical device companies must navigate complex, jurisdiction‑specific regulatory requirements (FDA, EU MDR/IVDR, UKCA, ISO 13485, MDSAP) using outdated, manual processes that consume time, burn runway, and delay market entry.
Solution
Dovetail offers a combined regulatory consultancy and SaaS platform that streamlines global approval pathways. Companies can either outsource the entire regulatory workflow to Dovetail’s expert team or use the platform’s tools to manage submissions themselves. The service provides end‑to‑end support—from quality‑management system implementation and technical file creation to multi‑jurisdiction submission and audit management—while maintaining secure, ISO 27001‑aligned data protection. By consolidating expertise and technology, Dovetail reduces the time and effort required to achieve compliance across multiple markets.
Target Audience
Primary customers are medical device manufacturers and startups seeking efficient, compliant market entry across multiple regulatory jurisdictions.
Features
- Dual engagement model: full‑service regulatory team or self‑service platform (“Envoy” and “QMS Plus”) to match client needs
- Integrated support for FDA, EU MDR/IVDR, UKCA, ISO 13485, and MDSAP submissions in parallel
- Secure handling of IP, design files, and trade secrets with NDAs and ISO 27001‑aligned security
- Transparent, milestone‑based pricing without hourly rates or hidden retainers
- Automated document generation and workflow management to replace manual Word/email processes
- Dedicated discovery calls and expert assessments to define the shortest regulatory path