Post-market surveillance
for medical devices
Start 14-day free trial- 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)
FSCA type
Safety alert + IFU update
RelevantMatches your device profile
94% confidenceMHRA — 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
62% confidenceFDA 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
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
...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 sources are queried in parallel. Results are deduplicated across databases.
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 evaluated by AI with a rationale you can verify and adjust. Nothing reaches the report unchecked.
BfArM12 Mar 2026
FSCA: Battery overheating in patient monitoring system during extended use
Drägerwerk AG · Patient monitor (Class IIb)
RelevantSame device class and intended use. Battery subsystem overlap with your device profile.
94% matchMHRA28 Feb 2026
Medical Device Alert: Software defect in vital signs display during SpO2 monitoring
Philips Healthcare · Vital signs monitor (Class IIb)
RelevantEquivalent device function. SpO2 display error relevant to patient monitoring safety.
87% matchFDA MAUDE15 Feb 2026
Adverse event report: Intermittent network connectivity loss in wireless patient telemetry
GE HealthCare · Wireless telemetry system (Class IIa)
UncertainDifferent device class, but shared wireless protocol. PRRC review recommended.
52% matchSwissmedic03 Jan 2026
FSCA: Updated labelling for single-use endoscopic stapler cartridges
Ethicon (Johnson & Johnson) · Surgical stapler (Class IIb)
ExcludedSurgical device, unrelated device class and intended use. No overlap with patient monitoring.
97% confidencePricing
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, Word & Excel reports
- Email support
Start free trialProMost popular
€599 /mo
- 10 device profiles
- 50 searches per month
- PDF, Word & Excel reports
- Priority support
Start free trialEnterprise
Custom
- Unlimited profiles
- Unlimited searches
- SSO integration
- Dedicated account manager
Contact salesReady to automate your post-market surveillance?
Start your free trial today. Set up your first device profile in two minutes.