MedTech platform
DOZI AI MedOps
The platform for the lifecycle of medical devices, from development to market.
From the development record and the submission, through finding the right distributor and regulatory matching, to training and certification - four products that work together, each stage feeding the next.
Scout in action - finding the right distributor in any market
Four products. One lifecycle.
Development & submission
Design
The design history builds itself during development, not the night before submission.
Design takes a medical-device company from idea to submission: classification, design controls, risk file, biocompatibility plan and stage gates. Every row rests on a cited standard and is signed by a named person. When submission comes, the file already exists and moves to Sentinel in one click.
- Classification wizard - questions from MDR Annex VIII; returns the class, the rule it rests on, and what is still open
- Design controls - inputs, outputs, verification and validation, and the traceability matrix between them under ISO 13485 clause 7.3
- Risk file under ISO 14971 - every hazard linked to the input that mitigates it; an open hazard is flagged, never closed by the system
- Biocompatibility plan from the ISO 10993-1 table - by contact type and duration: required, justify omission or not applicable, with the decision recorded
- Stage gates - concept, feasibility, bench, preclinical, clinical, submission; a gate opens only when its checklist is complete or every gap carries a signed waiver
- AI agents that propose and cite - for example hazards for the device type; a person accepts or rejects every proposal
- One-click handover to Sentinel - approved documents move in as classified submission evidence
Founders and R&D leads at device companies, before the first regulatory hire.
Discovery & matching
Scout
Find the right distributor before your competitor does.
Scout scans regulators, international expos, professional networks and map databases, and produces a full decision dossier for every distributor - including portfolio-gap analysis, country-tuned fit scoring and a first-outreach draft in the local language. Instead of weeks of manual research - a single working day.
- Multi-source scanning - regulators (AEMPS, EUDAMED, FDA, AMAR, ANVISA), expos (SEME, IMCAS), LinkedIn, Google Maps
- Portfolio-gap analysis (MAO) - identifies what a distributor already sells, and where your product completes the line
- Country-tuned scoring - criteria that know the local market, not a generic formula
- A decision dossier per distributor - identity, track record, regulation, contact, fit rationale, verified evidence
- A first-outreach draft - in the local language, grounded in a specific finding about that distributor
- Fallback mode - even in a country not yet deeply scanned, the top five distributors in one click
- Global architecture - adding a new country: one regulator adapter and one expo source. A day's work, not a project
A business-development manager who opens a new market in a week - not a quarter.
Regulatory monitoring
Sentinel
Regulation moves. You will know first.
Sentinel continuously monitors every authority relevant to your product portfolio - AMAR, AEMPS, EUDAMED, FDA, ANVISA - filters out the noise, and alerts you only on a change that touches you. Every alert arrives with an impact analysis and a drafted contract addendum, ready to sign.
- Multi-authority monitoring - five core regulatory authorities, expandable on demand
- Smart filtering - strips out cancellations, minor wording changes and noise; alerts only on a material change
- Automatic impact analysis - which product, which active contract, which country - flagged the moment the alert fires
- A drafted contract addendum - a ready DOCX, clauses adapted to the new regulation, straight to signing
- Linked to Academy - a product label changed? every course that cites it lights up red
- A full historical record - every change, decision and response - documented under 21 CFR Part 11
A regulatory manager who handles a change the day it happens - not the quarter after.
Training & certification
Academy
From your documents to a course, and from the course to a certified distributor.
Academy lets you upload courses and certifications per product, connect your existing Academy as the infrastructure, and ensure every active distributor is trained and certified - with documentation that passes a regulatory audit. The course studio builds a course from your company's own documents, and when a product label or protocol changes, Sentinel flags which courses need updating.
- Company course studio - upload your documents and AI drafts a course: lessons, images, charts and check questions, each pointing back to its source
- Full editing - every lesson, image, chart and question can be edited or rebuilt on its own, without losing the rest
- Two-person approval - whoever built a course cannot approve it alone
- Private company courses - internal training material never appears in the public catalog
- Full course management - video, PDF, SCORM, graded tests, certification expiries
- Certification badges - attached to the distributor profile; they become a trust signal on their Scout listing
- Regulatory sync - a label or protocol change instantly flags the affected courses
- Analytics - completion rates, test scores, certification expiries - on one dashboard
Certification is not a booklet. It is an asset that moves measurable sales outcomes.
Design builds. Scout finds. Sentinel monitors. Academy certifies.
Complete infrastructure for your medical devices, from development to distributors, in every country.
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