Compliance Monitor

Never be caught off guard by a regulatory change that invalidates your dossier.

Regulatory landscapes change constantly. A new FDA guidance document, an updated EMA IVDR rule, or an ANVISA RDC amendment can invalidate sections of your dossier overnight. The Compliance Monitor scrapes all four regulatory agencies daily and runs each publication through your project's regulatory profile to determine whether it affects you — and how urgently.

How it works

Daily Scraping

ANVISA DOU, FDA Federal Register and guidance documents, EMA EUDAMED updates, and Health Canada notices are scraped every 24 hours.

Project Matching

Each publication is matched against your project's product class, regulatory pathway, and submission sections. Only relevant updates trigger alerts.

Impact Scoring

Alerts are scored 0–100 for urgency: mandatory rules score 75–90, recalls score 90–100, guidance documents score 50–70. You see what needs immediate attention.

Notification & Action

Alerts appear in your project dashboard and are sent by email. Each alert links to the affected dossier section with a recommendation for how to address it.

What's included

✓Daily scraping: ANVISA DOU, FDA Federal Register, EMA EUDAMED, Health Canada
✓Project-specific matching — only relevant alerts reach you
✓Urgency scoring 0–100 (recall > mandatory rule > guidance > notice)
✓Dossier section linking — each alert maps to the affected section
✓Email notifications with configurable frequency
✓Alert history and audit log
✓ICH-GCP updates for clinical trial compliance

Coverage

🇺🇸

United States — FDA

FDA Federal Register — final and proposed rules
FDA Guidance Documents (CDRH, CDER, CBER)
FDA Recalls and Safety Alerts
21 CFR regulatory updates
CDRH Device Classification Database changes

🇪🇺

Europe — EMA

EUDAMED — device and certificate updates
EMA Scientific Guidelines and Opinions
MDR/IVDR implementing acts
Notified Body accreditation changes
MedEthicsEU ethics guidance

🇧🇷

Brazil — ANVISA

Diário Oficial da União (DOU) — ANVISA publications
RDC amendments
IN (Instruções Normativas)
ANVISA Recalls and Safety Alerts
CONEP/INAEP research ethics updates

🇨🇦

Canada — Health Canada

Health Canada Medical Device Notices
Health Product Info Watches
SOR regulatory amendments
TCPS 2 and REB guidance updates

Who is it for

Regulatory affairs professionals with active submissions in review
Teams managing post-market surveillance obligations
Quality managers responsible for design history file currency
CROs managing client dossiers across multiple jurisdictions
Startups tracking FDA guidance for their product category

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