Stop manually searching the FDA's MAUDE database. Get AI-powered adverse event alerts and compliance-ready reports delivered to your inbox weekly.
Features
From automated data collection to compliance-ready reporting, DeviceWatch handles the heavy lifting so your team can focus on patient safety.
Connects to the openFDA API to automatically pull new adverse event reports for your specific product codes every week.
Claude AI analyzes dense clinical narratives to extract failure modes, severity levels, and executive summaries.
Qualified QA professionals review and acknowledge AI summaries before they enter your compliance documentation.
Spot systemic issues with visual dashboards showing event frequency, severity distribution, and emerging signals.
Immutable audit trails, access controls, session timeouts, and data integrity verification built in from day one.
Receive formatted safety signal reports directly in your inbox, grouped by product code and severity.
Pricing
Choose the plan that fits your team. All plans include a 14-day free trial.
For small teams getting started with post-market surveillance.
For growing teams that need deeper insights and collaboration.
For enterprises requiring full regulatory compliance tooling.
FAQ
Everything you need to know about DeviceWatch and FDA MAUDE surveillance.
The FDA MAUDE (Manufacturer and User Facility Device Experience) database is a publicly available repository of medical device adverse event reports submitted to the FDA. It contains reports of device malfunctions, injuries, and deaths associated with medical devices. DeviceWatch automatically monitors MAUDE for reports relevant to your products and delivers AI-analyzed summaries weekly.
DeviceWatch uses advanced AI (Claude by Anthropic) to analyze dense clinical narratives from FDA MAUDE reports. The AI extracts key information including failure modes, severity levels, patient outcomes, and root cause indicators, then generates concise executive summaries. All AI-generated content goes through a human-in-the-loop review process before entering your compliance documentation.
Yes. DeviceWatch is built with 21 CFR Part 11 compliance requirements in mind. This includes immutable audit trails for all actions, role-based access controls, automatic session timeouts, data integrity verification, and exportable audit logs. These features ensure your post-market surveillance documentation meets FDA electronic records requirements.
Absolutely. DeviceWatch allows you to track adverse events for competitor devices alongside your own products. This competitive intelligence helps you benchmark your safety profile, identify industry-wide trends, and proactively address emerging issues before they affect your devices. Competitor tracking is available on Growth and Compliance Pro plans.
A PSUR (Periodic Safety Update Report) is a regulatory document that provides a comprehensive assessment of a medical device’s benefit-risk profile. DeviceWatch automates PSUR preparation by aggregating adverse event data, generating trend analyses, and producing compliance-ready reports with signal detection summaries. This reduces weeks of manual work to hours.
While Greenlight Guru focuses broadly on quality management systems (QMS) for medical devices, DeviceWatch specializes specifically in post-market surveillance and FDA MAUDE monitoring. DeviceWatch offers AI-powered adverse event analysis, automated signal detection, competitor device tracking, and PSUR report generation—capabilities purpose-built for post-market teams that complement broader QMS platforms.
Join medical device teams who trust DeviceWatch to keep them informed, compliant, and ahead of safety signals.