Post-market surveillance
for medical devices
Start 14-day free trial- Search BfArM, FDA MAUDE, MHRA, and Swissmedic in parallel
- AI classifies every Field Safety Notice against your device profile
- Your PRRC reviews every decision before export
- Audit-ready PDF and Word reports in minutes
BfArM — Field Safety NoticeBfArM/FSN-2026-0847
FSCA: Potential battery overheating in patient monitoring system during extended use
Device class
Patient monitor (IIb)
FSCA type
Safety alert + IFU update
Risk
Device shutdown during critical monitoring
RelevantMatches your device profile
94% confidenceMHRA — Medical Device AlertMHRA/MDA-2026-014
Infusion pump software update: risk of incorrect dose delivery in paediatric mode
Device class
Infusion pump (IIb)
UncertainRequires further review
62% confidenceFDA MAUDE — Adverse EventFDA/MW-10284751
Dental implant abutment fracture reported during routine follow-up examination
Device class
Dental implant (III)
Not RelevantDifferent device category
97% confidenceBfArM — Field Safety NoticeBfArM/FSN-2026-0847
FSCA: Potential battery overheating in patient monitoring system during extended use
Device class
Patient monitor (IIb)
FSCA type
Safety alert + IFU update
Risk
Device shutdown during critical monitoring
RelevantMatches your device profile
94% confidenceUnified Access
Four supported databases in one interface
BfArMGermany
FDA MAUDEUnited States
MHRAUnited Kingdom
SwissmedicSwitzerland
How it works
Three steps to your PMS report
01
Define your device profile
Enter device name, manufacturer, and classification. Neuridion generates optimised search terms for each regulatory database.
02
Run a search
Select date range and databases. All sources are queried in parallel. Results are deduplicated across databases.
03
Review and export
AI classifies each FSN as relevant, uncertain, or excluded. Your PRRC reviews every decision before the report is finalised.
Real classification output
Every FSN, classified against your device
Each Field Safety Notice from the search is classified by AI with a rationale your PRRC can verify. Nothing reaches the report unchecked.
BfArM12 Mar 2026
FSCA: Battery overheating in patient monitoring system during extended use
Patient monitor (Class IIb)
RelevantSame device class and intended use. Battery subsystem overlap with your device profile.
94%MHRA28 Feb 2026
Medical Device Alert: Software defect in vital signs display during SpO2 monitoring
Vital signs monitor (Class IIb)
RelevantEquivalent device function. SpO2 display error relevant to patient monitoring safety.
87%FDA MAUDE15 Feb 2026
MDR report: Intermittent network connectivity loss in wireless patient telemetry
Wireless telemetry system (Class IIa)
UncertainDifferent device class, but shared wireless protocol. PRRC review recommended.
52%Swissmedic03 Jan 2026
FSCA: Updated labelling for single-use endoscopic stapler cartridges
Surgical stapler (Class IIb)
ExcludedSurgical device, unrelated device class and intended use. No overlap with patient monitoring.
3%Pricing
Plans for every team size
14-day free trial on all plans. All prices excl. VAT.
Starter
€199 /mo
- 3 device profiles
- 15 searches per month
- PDF reports
- Email support
Start free trialProMost popular
€599 /mo
- 10 device profiles
- 50 searches per month
- PDF + Word reports
- Priority support
Start free trialEnterprise
Custom
- Unlimited profiles
- Unlimited searches
- SSO integration
- Dedicated account manager
Contact salesReady to automate your PMS workflow?
Start your free trial today. Set up your first device profile in two minutes.