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MAUDE
A Riskbased.ai productUS FDA device adverse-event intelligence for MedTech quality, regulatory, and competitive-intelligence teams. Detect risk signals before they escalate, track recalls, and benchmark competitors on postmarket MDR data. Pick an app below and it loads right here in the window.
Medical Devices
| App | Scope | What it does | |
|---|---|---|---|
| FDA AEMS | All manufacturers | The latest version of the FDA Adverse Event Monitoring System. | Coming soon |
| MAUDE 3.5 | All manufacturers | Medical Device Reports (MDR) per 21 CFR 803. Research and analyze MDRs across manufacturers, brands, and product codes with full filtering. | Viewing |
| AlphaSPIKE | All manufacturers | Risk family trending with moving averages and standard-deviation indexes. Surfaces statistical spikes and drifts that signal product problems happening behind the scenes. | Platform |
| AI Summary | All manufacturers | Natural-language processing on MDR narratives. AI tagging simplifies keyword categorization and enriches data depth for trending, HHA, FMEA, and risk work. | Platform |
| AI Agents | Insulet | Three dedicated LLM agents over the complaint data: unusual and novel complaints, leak complaints that are not misuse, and foreseeable-risk adjudication. | Platform |
| Competitor Jux | Insulin & CGM category | Competitor juxtaposition: side-by-side MDR benchmarking for the insulin-pump and CGM landscape, with weekly and monthly views, heatmaps, and death/injury tracking. | Platform |
| Custom KPIs | Insulet | Insulet Corp Omnipod custom KPIs: master table, counts plus glycemia views, and adverse-event breakdowns tailored to their product monitoring workflow. | Platform |
| FDA Audit AI | Insulet | An audit-preparation agent that generates FDA readiness questions from the complaint data, so quality teams can rehearse what an investigator would ask. | Platform |
| HHA Ideas | Insulet | Agents for Health Hazard Assessment and evaluations: find an MDR, evaluate it, and adjudicate the risk (severity by occurrence). | Platform |
| Recall Database | All manufacturers | FDA device recall database with automated alerts for vigilance and awareness across product classes and device codes. | Platform |
| Meta Analysis | All manufacturers | The perspective of the regulator: predict FDA behavior with data. Holistic MDR metrics, month-over-month trends, and the 4-quadrant adverse-event by product-problem risk matrix. | Platform |
| Keyword Isolation | All manufacturers | Isolate keywords across MDR text (brands, components, failure terms) and track adverse versus non-adverse trends over months to spot patterns and emerging risks. | Platform |
MAUDE · Free explorer
Medical Device Reports (MDR) per 21 CFR 803. Research and analyze MDRs across manufacturers, brands, and product codes with full filtering.
MAUDE data is voluntarily reported and may be incomplete, inaccurate, or unverified. A report does not establish that a device caused or contributed to an adverse event. Use this data for signal detection and research only, not as the sole basis for regulatory or clinical decisions.