Product Documentation
Med Journey AI
Marketing collateral and reference attachments for the medical-device drafting platform. Each piece stands on its own; together they describe what MJAI is, what it covers, and how it flows.
Product DescriptionOpen · PDFCopyright 2026
Med Journey AI — Product Description
A medical-device commercialization platform built to the standard of the most aggressive FDA reviewer — at any scale, from a single founder to a multinational CMO running hundreds of programs. Covers the Company → Program → Component hierarchy, per-component DHF (21 CFR §820.30), Process Controls stack, Document Vault with audit trail, semantic search, multi-reviewer approval, and the Early Warning System. With portfolio dashboard + component drill-down screenshots.
Foundational System ComponentOpen · PDFCopyright 2026
Document Vault
The central piece of Medical Device Content Generation. Every artifact lives in the Vault as an immutable, versioned, audit-logged snapshot — with multi-reviewer approval workflow, semantic search, and a timestamped chain of custody behind every billable event. Covers version management, audit trail, the approval state machine, customer-approval as the billable trigger per SOW, and the standards the Vault produces records that satisfy (21 CFR Part 11, §820.40, §820.30, ISO 13485, MDR Annex II/III).
Attachment ACoverage Map · PDFJune 2026
Coverage Map — Classifications
Maps every MJAI capability to every FDA and EU regulatory pathway: Class I, II (510(k), De Novo) with General + Special Controls callouts, III (PMA), HDE, MDR I/IIa/IIb/III, IVDR A/B/C/D. Use this when a prospect asks "do you cover my pathway?".
Attachment BPDF · 1 pageJune 5, 2026
Workflow Stages — Leave-Behind
A one-page printable that mirrors the workspace left-rail: Project → Foundation → Risk & Quality → Compliance → Repository → Project Mgmt → Company. Use as the "how it flows" companion to the Platform overview during sales conversations.
InternalArchitecture noteJune 5, 2026
Bollong.AI Navigation Architecture
Internal recommendation on splitting "About" from "Resources" in marketing nav (the pattern this very page follows). Includes the rationale, comparable examples, and outlines of what should live on each About page. Useful when revisiting site IA.