DeviceWatch
Keep up with FDA MAUDE reports for your devices without searching the database by hand. DeviceWatch gathers the reports, analyzes clinical narratives and drafts safety reports for qualified review.
- My role
- Independent developer
- Status
- Live web app
Inside the app
Dashboard, review queue and report history from the demo workspace. Select an image to view it full size.
From adverse event reports to review
Keeping up with MAUDE
Monitoring device reports means finding the relevant entries, reading the narratives and keeping a record of what needs attention. I built DeviceWatch to gather that material and put it into a review workflow.
Gathering and analyzing reports
Built on Next.js with Supabase for auth and data, DeviceWatch ingests MAUDE reports automatically, then uses Claude AI to parse clinical narratives, identify failure modes, classify severity and draft PSUR, trend analysis and CAPA reports for review.
Traceability and qualified review
The design includes audit trails, role-based access and data integrity controls to support regulated workflows. AI-generated assessments need traceable sources and qualified review before use in regulatory decisions.
Making assessments auditable
Building for regulated industries means every feature decision has compliance implications. Stripe billing, Resend transactional emails and Supabase RLS policies all had to be auditable. The AI prompts went through dozens of iterations to produce consistently structured clinical assessments.
Built with
See the Full Product
Visit the marketing site for features, pricing and a free trial.