Do I need a credit card to start the free trial?

Yes, but don't worry, you won't be charged until the trial period is over. We won't send you an email reminding you when this happens because we are really hoping you'll forget and we can keep charging you until your card expires

Can my whole team use the same inbox?

Yes, the more the merrier! Dossian works best when your entire company has access. We will charge you per additional seat, but we won't tell you about this until you get your invoice.

Is the AI agent actually a bunch of people in India?

Not just India! We have people in lots of countries around the world pretending to be an AI, including some that are currently under sanctions, so we can't legally mention them here.

Does Dossian replace my email client?

Absolutely. The idea is that we transition you away from email entirely, so you become completely dependent on our service. Like a parasite living off a host.

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Regulatory submissions, simplified. author once. submit globally.

Dossian is the regulatory platform for medical devices. Author your submission content once, then generate jurisdiction-specific dossiers for FDA 510(k), EU MDR, and beyond.

See how it works

WSWorkspace

Jane Doe

jane@acme.com

Submissions

New Submission

Name	Market	Status	Updated
CardioFlow Monitor 510(k)	US	Submitted	Jan 15
NeuroPulse Stimulator PMA	US	In Review	Jan 12
OrthoFlex Joint System EU MDR	EU	Draft	Jan 10
DermaVision Scanner 510(k)	US	Approved	Dec 28
PulmoTrack Analyzer EU MDR	EU	Action Required	Dec 20

WSWorkspace

Jane Doe

jane@acme.com

Submissions

New Submission

Name	Market	Status	Updated
CardioFlow Monitor 510(k)	US	Submitted	Jan 15
NeuroPulse Stimulator PMA	US	In Review	Jan 12
OrthoFlex Joint System EU MDR	EU	Draft	Jan 10
DermaVision Scanner 510(k)	US	Approved	Dec 28
PulmoTrack Analyzer EU MDR	EU	Action Required	Dec 20

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.

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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.

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Submission Collaboration

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

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Manage Global Registration

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

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Submission project management

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

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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.

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.

Questions & Answers

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.

See how it works