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Regulatory submissions, simplified. author once. submit globally.

Our regulatory platform for medical devices auto generate jurisdiction-specific submission dossiers including FDA eSTAR, EU MDR, and beyond from single globally alined submission.

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Dossian submission dashboard showing regulatory submissions across FDA, EU MDR, and PMDA markets
Dossian submission dashboard showing regulatory submissions across FDA, EU MDR, and PMDA markets
Platform capabilities

Everything you need to bring medical devices to market faster

Work smarter, move faster, and keep every submission details right where it belongs — in IMDRF ToC.

One click e-STAR submission generation

Auto-generate compliant 510(k), PMA, and De Novo submissions. Built-in validation against CDRH requirements, with section-by-section guidance.

Single source of truth, for all Market

IMDRF ToC native content slots allows to use content reuse across market, with support for region specific templates.

Submission Collaboration

Securely work with consultants, clients, and regional partners on shared submissions, with comments, version history and audit logs.

Manage Global Registration

Manage product registration and certificates lifecycle by country. Stay updated on upcoming expirations and renewals with automated alerts.

Submission project management

Assign tasks to internal or external (consultants, representative) team member. Automated dependency tracking and submission-ready checklists.

AI tools

Fleet of specialized AI agents that takes over the busy work, so you can focus on the strategy.

Human in the loop let you delegate research, gap analysis and summarization tasks to AI agents with confidence.

Regulatory pathway modeling

AI-guided workflow, helps with product classification, risk profile and a tests & standards plan.

Human in the loop

Our AI agents asks clarifying questions to remove ambiguity from any workflow.

Predicate analysis in seconds

AI agent finds similar devices instantly, compare key characteristics with confidence score and reasoning.

Frequently asked questions

Dossian is a regulatory platform for medical devices that helps teams prepare global submissions. It's built for in-house regulatory affairs teams managing submissions across multiple markets, as well as regulatory consultants and consulting firms serving multiple medical device clients.
Dossian supports FDA 510(k) e-STAR generation, EU MDR Technical Documentation, and more jurisdictions are on the way. Content is structured using the IMDRF Table of Contents format, so you can author once and generate submission-ready dossiers for each market automatically.
Our AI assists with predicate search, product classification, and regulatory pathway strategy. It's always human-in-the-loop — the AI asks clarifying questions to remove ambiguity, surfaces relevant data, and suggests next steps, but you make the final decisions.
Yes. Dossian includes built-in electronic signatures, configurable approval workflows, and complete audit trails for every document change and decision — giving you and your auditors full traceability out of the box.

Ready to simplify your next regulatory submission?

Author your regulatory content once, generate submission-ready dossiers for every market, and let AI-powered tools guide you through predicate search, classification, and pathway strategy.

Get early platform access