Dozio provides a cloud‑based compliance platform for medical device manufacturers that centralizes all regulatory artifacts into a single, continuously updated system. The platform automatically propagates changes in EU MDR standards, guidance, and product data across modules, generating audit‑ready technical files, living clinical evaluation reports, and post‑market surveillance plans with a unified audit trail for instant inspection readiness.
Funding
Funding not disclosed
Founders
Product
Problem
Medical device manufacturers must manage compliance across multiple disconnected tools, spreadsheets, and binders, making it difficult to keep technical documentation, clinical evaluations, and post‑market surveillance up to date with evolving EU MDR regulations.
Solution
Dozio offers a cloud‑based compliance platform that unifies all regulatory artifacts into a single, continuously updated system. The platform maintains a shared regulatory corpus, so any change to standards, guidance, or product data automatically propagates to all relevant modules. It generates audit‑ready Annex II technical files, living clinical evaluation reports, and post‑market surveillance plans that reflect the latest evidence and regulatory updates. Integrated regulatory intelligence pulls MDCG guidance, harmonised standards, and alerts from EUDAMED and FDA MAUDE, ensuring users are notified of changes in real time. All actions are recorded in a unified audit trail, providing instant readiness for inspections and audits.
Target Audience
Dozio is designed for medical device manufacturers, regulatory affairs teams, and quality management professionals who need a unified, continuously compliant system to manage EU MDR obligations.
Features
- Centralized regulatory corpus with a single source of truth for all compliance documents
- Automated generation and continuous maintenance of Annex II technical files
- Living clinical evaluation reports that update as new literature and evidence become available
- Post‑market surveillance module linking PMS plans, PSURs, and incident tracking to the technical file
- Real‑time regulatory intelligence feed delivering MDCG guidance, standards updates, and alerts from EUDAMED and FDA MAUDE
- Integrated signal detection that monitors field data alongside external databases for early safety insights
- End‑to‑end audit trail capturing every change for instant audit readiness