Search BfArM, FDA MAUDE, MHRA, and Swissmedic in parallel
AI evaluates every Field Safety Notice against your device profile
Review every decision with a rationale you can verify — then export in PDF, Word, or Excel
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
Manufacturer
Drägerwerk AG
Device class
Patient monitor (IIb)
Date issued
12 Mar 2026
FSCA type
Safety alert + IFU update
RelevantMatches your device profile
Model confidence 94%
MHRA — Medical Device AlertMHRA/MDA-2026-014
Infusion pump software update: risk of incorrect dose delivery in paediatric mode
Manufacturer
B. Braun Melsungen AG
Device class
Infusion pump (IIb)
UncertainRequires further review
Model confidence 62%
FDA MAUDE — Adverse EventFDA/MW-10284751
Dental implant abutment fracture reported during routine follow-up examination
Manufacturer
Nobel Biocare (Envista)
Device class
Dental implant (III)
Not RelevantDifferent device category
Model confidence 97%
BfArM — Field Safety NoticeBfArM/FSN-2026-0847
FSCA: Potential battery overheating in patient monitoring system during extended use
Device class
Patient monitor (IIb)
Date issued
12 Mar 2026
FSCA type
Safety alert + IFU update
Risk
Device shutdown during critical monitoring
RelevantMatches your device profile
Model confidence 94%
Unified Access
Four supported databases in one interface
BfArMGermany
FDA MAUDEUnited States
MHRAUnited Kingdom
SwissmedicSwitzerland
...many more coming soon
How it works
Three steps to your PMS report
01
Define your device profile
Neuridion integrates into your PMS strategy. Define your device profile or upload your predefined search strategy and product profiles.
02
Run a search
Select monitoring period and databases. All selected databases are searched in parallel. Every result shows the database it came from.
03
Review and export
AI evaluates each FSN as relevant, uncertain, or excluded. Review every decision before the report is finalised. Export in various formats.
Real assessment output
Every FSN, matched against your device profile
Each Field Safety Notice from the search is assessed by AI with a rationale you can verify and adjust. Nothing reaches the report unchecked. Model confidence is the model's own indicator, not a calibrated probability.
BfArM12 Mar 2026
FSCA: Battery overheating in patient monitoring system during extended use
Drägerwerk AG · Patient monitor (Class IIb)
Relevant
Same device class and intended use. Battery subsystem overlap with your device profile.
Model confidence 94%
MHRA28 Feb 2026
Medical Device Alert: Software defect in vital signs display during SpO2 monitoring
Surgical device, unrelated device class and intended use. No overlap with patient monitoring.
Model confidence 97%
Pricing
Plans for every team size
Free trial: 1 search run and 1 product profile on the BfArM database. No credit card required. Paid plans are billed monthly. You can subscribe at any time from Billing. All prices excl. VAT.