For medical-device quality and regulatory teams
Review MAUDE evidence for your product codes.
DeviceWatch brings available FDA device reports, provisional AI summaries and analysis coverage into one review workflow. Bring one product code for a 30-minute walkthrough.
Growth is $499/month.Try Growth for 14 days. No credit card required.
Follow the evidence through the review.
These are the steps we will inspect together, using records available for your search.
- 01
Inspect the source records
Choose an FDA product code. Open available MAUDE reports, their source identifiers and the narratives FDA has published.
Collection status shows what has been retrieved. A pending or partial collection cannot establish that no matching reports exist.
- 02
Check analysis coverage
Where analysis is available, compare the provisional summary and extracted findings with the source narrative.
Collected records and completed analyses are separate counts. Missing narratives, pending work and failed processing remain visible.
- 03
Make a human review decision
See how a reviewer acknowledges, flags or rejects an analysis and records a signed review decision.
AI output requires qualified review. Your team decides what the evidence supports and whether further investigation is needed.
Know the scope before you start.
The walkthrough is a chance to check whether the available evidence and workflow fit your team's recurring review task.
Read our security and compliance postureCollection has limits
Updates are periodic and depend on FDA availability. Initial imports are bounded and may be partial. MAUDE records can be incomplete; a report does not establish that a device caused an outcome. If your search has no available matching records, we will show that state.
Analysis needs review
AI summaries are provisional. Collection finishing does not mean every narrative has been analyzed. Qualified reviewers must check the source and decide what action, if any, is appropriate.
PSUR and PMS reports require Compliance Pro
Compliance Pro is $999/month and has a separate evaluation conversation. PSUR and PMS drafts are Pro features; the 14-day Growth trial covers Growth features. Report drafts still require your team's review and validation.
Discuss Compliance ProStart with one review task.
Choose a walkthrough time. We will inspect one product code, check the available coverage and discuss the workflow. If Growth fits, start the optional trial with help adding your first code.
Growth: $499/month after the 14-day trial. No credit card required to try it.