Enzyme

Enzyme is a Y-Combinator-backed regulatory-intelligence platform built for life-science companies that need to place medical devices, diagnostics or combination products on global markets. Instead of hiring external consultants or maintaining fragmented spreadsheets, teams subscribe to Enzyme’s cloud workspace where FDA, EU MDR, Health Canada, PMDA and TGA requirements are continuously mapped to the product’s design-dossier.

Main features extracted from the site
1. Dynamic Regulatory Map
A living matrix shows exactly which standards (ISO 13485, IEC 62304, ISO 14971, 21 CFR Part 820, etc.) apply to each device class and automatically updates when guidances change.

2. Design-Dossier Builder
Drag-and-drop modules compile risk files, DHF, TF, 510(k) summaries, clinical evidence and post-market surveillance into one structured, audit-ready dossier that can be exported to eSTAR, STED or EU MDR formats.

3. AI Gap Analysis
One click compares current documentation against the chosen submission pathway; the engine flags missing data, suggests pre-written text and predicts FDA review questions with cited predicates.

4. Collaborative QMS
Built-in CAPA, management review, supplier audit and training records are linked to the device record so quality events instantly update risk files and labeling without duplicate data entry.

5. Submission Project Plans
Gantt-style timelines auto-populate with FDA or Notified-Body milestones, assign owners and send Slack/Teams reminders; burn-down charts forecast submission readiness in real time.

6. Predicate & Clinical Benchmark Engine
The platform indexes 100 k+ 510(k), PMA, De Novo and EU technical files; natural-language search surfaces predicate devices, clinical endpoints and comparative performance data to shorten literature-review time by 70 %.

7. Post-Market Surveillance Hub
Automated scraping of FDA MAUDE, EU EUDAMED, customer complaints and social media feeds creates real-time safety dashboards; algorithms trend risk scores and trigger CAPA before events become reportable.

8. Enterprise Compliance Layer
Role-based permissions, electronic signatures, full audit trails and SOC-2-certified cloud hosting satisfy 21 CFR Part 11 and EU Annex 11 so both start-ups and Fortune 500 auditors can rely on the same system.

By integrating regulation, quality and submission workflows in one AI-augmented workspace, Enzyme claims it can cut documentation effort by 50 % and accelerate market entry by six months or more.