Detection
Emerging signal detection
Surface weak signals across complaints, MAUDE, literature and field data — before they cluster into a recall.
Predict · The platform
From signal to action.
Enterprise Risk Intelligence for medical device manufacturers. Identify emerging risk earlier, prioritize what matters, and act with confidence.
01 / How it works
Four stages, one chain of evidence.
Every signal carries its sources and timestamps forward, so the decision at the end can be defended.
Step 01
Signals
Collect data from internal & external sources.
Step 02
Patterns
AI/ML detects patterns and emerging signals.
Step 03
Insights
Risk scoring and prioritization.
Step 04
Action
Drives decisions and prevents harm.
02 / Capabilities
Platform capabilities.
Everything needed to take fragmented safety data and turn it into prioritized, defensible decisions.
Triage
Risk prioritization
Score and rank what matters so teams focus on the highest-impact risk first.
Trajectory
Trend analysis
Catch escalation early by tracking trajectories over time.
Decision
Decision support
Turn intelligence into clear, defensible next actions.
Governance
Governance & audit trail
21 CFR Part 11-friendly records with timestamps and source references on every signal.
Coverage
Lifecycle coverage
Monitoring aligned to FDA MDR, EU MDR, and global post-market surveillance expectations.
03 / Why it matters
Most organizations react. Leaders predict.
Detecting signals early prevents harm, reduces cost, and protects your brand.
80%
of recalls show warning signs months earlier
7–12 mo
median time from first signal to recall
440M
device units affected by US recalls in 2024 — up 55% on 2023
1,059
US device recall events in 2024, a four-year high
2024 US recall figures: Sedgwick State of the Nation Recall Index, 2025 edition.
04 / The vision
From reactive compliance to predictive intelligence.
We believe safety should be predictive, not reactive. RP360 is building the intelligence layer that sees risk first — quietly, continuously, across the noise.
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Predict the future of medical device safety.
Detect risks earlier. Prevent harm. Save lives.