01
Volume
10,000+ adverse event reports every month.
Cardiology devices alone generate a constant stream of MDRs. No team is reading all of them.
Post-Market Surveillance Intelligence
Spot adverse event spikes weeks before they hit your desk
Thousands of MAUDE reports land every week. Claripulse watches all of them — and alerts you only when the statistics say something is wrong.
~1M
Reports Analyzed
10K+
Devices Monitored
Weekly
Updates
200+
Active Signals
The problem
MAUDE reporting is growing. Manual review isn't scaling.
02
Signal vs. noise
The real signal is buried in routine paperwork.
Whether you’re filing MDRs or evaluating device risk, the few reports that matter look identical to the thousands that don’t.
03
Timing
By the time a trend is obvious, it’s already too late.
Recalls, FDA letters, and 483s arrive after the pattern was sitting in the data for months.
Claripulse replaces the spreadsheet with statistical surveillance.
See how Claripulse compares to manual MAUDE searchHow it works
From raw data to safety intelligence
Three automated steps transform FDA adverse event reports into actionable signals — no manual review required.
01
Step 01
Ingest
Every week, the latest MAUDE reports are automatically pulled, normalized, and matched to your device catalog. No downloads, no data wrangling.
02
Step 02
Detect
Five statistical models scan for anomalies — sudden spikes, creeping trends, new failure modes, and devices reporting above their peer group.
03
Step 03
Alert
Only statistically significant signals reach your dashboard — ranked by severity, with full device context and historical baselines. No noise.
Never miss a safety signal again
Claripulse runs five detection algorithms every week — so emerging safety signals surface in your dashboard, not buried in a backlog of unread reports.
- Adaptive thresholds that account for device maturity — new devices aren’t held to legacy baselines
- Severity-ranked alerts so your team focuses on what matters most
- Zero-noise tuning — only statistically significant anomalies surface
Active Signals
3 detected · last 7dICD Lead. Spike detected
Critical12 reports this week vs. 3 avg
Drug-eluting stent. Trend up
WarningRising 18% over 90 days
EP catheter. New problem code
InfoFirst occurrence of code 2993
Complete device intelligence in one place
Stop cross-referencing MAUDE downloads with GUDID lookups and 510(k) databases. Every device gets a unified profile with report history, event breakdowns, and regulatory context.
- Automatic GUDID matching across 4,200+ devices — no manual catalog maintenance
- Manufacturer normalization resolves naming variants automatically
- PMA and 510(k) clearance data cross-referenced in context
- Feeds your ISO 14971 risk management file with traceable adverse-event references
Device Profile
Cardiac Resynchronization Therapy Defibrillator
Product code: MKJ | Medtronic
1,847
Total Reports
+12%
30-day Change
3/18
Peer Rank
Malfunction
Injury
Death
Other
Seven years of trends, one click away
See how any device’s adverse event profile has evolved over seven years. Compare it against its peer group to know instantly if a trend is device-specific or category-wide.
- Interactive trend charts spanning 2019 to present
- Peer-group benchmarking shows outliers at a glance
- 30-day and 90-day momentum indicators flag emerging issues early
Report Trend
6M1YAll
Spike detected
90-day change
12%
Weekly avg
14.3
Powered by FDA data. Driven by statistics.
Three authoritative data sources, six detection algorithms, 1M+ adverse event records, and a dashboard built for post-market surveillance teams.
Data Sources
01
Source 01
FDA MAUDE
Complete adverse event and malfunction reports — automatically ingested and normalized every week.
02
Source 02
GUDID Registry
FDA’s Global Unique Device Identification database — used to match and enrich every device profile.
03
Source 03
openFDA API
PMA approvals, 510(k) clearances, and regulatory context — cross-referenced with every signal.
Built For
Detect signals before they become FDA inquiries
Track emerging adverse event spikes across your device portfolio with statistical baselines that account for device maturity. Know exactly how many days of lead time you have before enforcement thresholds are reached.
claripulse / dashboard / regulatory-affairs
Signal Timeline
FDA threshold
JanDec
14
days early
avg. detection lead time
Active Signals
TAVR lead migrationspike
ICD battery anomalytrend
CRT-D connectorwatch
Get signal alerts before everyone else
Join the early access list for twice-a-month signal digests covering cardiology devices. Free during beta.