Reduce Preventable Harm from Medical Devices
Detect emerging safety signals earlier — so fewer patients are exposed before action is taken.
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The Hidden Cost of Delayed Detection
Medical device issues rarely appear suddenly. They emerge as weak signals over time — recognized late, acted on after escalation, while patients remain exposed during the delay.
Signals Recognized Late
Weak safety signals go unnoticed until they cross critical thresholds, delaying response.
Action Follows Escalation
Teams react only after problems have already escalated, increasing the scale of intervention required.
Patients Exposed During Delay
Every day between signal emergence and action results in continued patient exposure to emerging risks.
RP360 — Early Risk Detection for Medical Devices
RP360 helps organizations identify emerging safety patterns earlier, enabling faster and more informed decisions. We transform fragmented safety data into clear signals, trackable trends, and actionable insights.
Teams can act before problems escalate.
How It Works
Identify Emerging Patterns
Continuously monitor real-world signals to detect early changes before they become trends.
Structure Signals Clinically
Organize events into meaningful clinical patterns that support investigation and decision-making.
Track Changes Over Time
Understand how risk evolves relative to expected behavior across the device lifecycle.
Highlight Critical Signals
Prioritize areas requiring attention so teams focus on what matters most.
Enable Earlier Action
Support faster investigation and intervention — reducing the window of patient exposure.
Why Timing Matters
Every delay between signal emergence and action results in continued patient exposure. RP360 reduces that delay.
Patient Impact
- Fewer patients exposed to emerging risks
- Reduced severity of complications
- Earlier intervention opportunities
Financial Impact
- Reduced scale and severity of recalls
- Lower downstream cost and liability
- Improved operational efficiency
Operational Impact
- Faster signal visibility
- Better prioritization
- Reduced investigation burden
From Signal to Action — Faster
Without RP360
With RP360
We reduce the exposure window.
Built for Decision-Making, Not Reporting
RP360 is not a reporting system or compliance tool. It is a decision support platform for early risk detection. We don't replace existing processes — we make them start earlier.
Regulatory Alignment
FDA MDR Readiness
Align your safety processes with FDA Medical Device Reporting requirements through structured signal tracking.
EU MDR Article 88 Compliance
Support trend reporting obligations under EU MDR with continuous lifecycle monitoring and analysis.
Global Lifecycle Monitoring
Meet international post-market surveillance expectations with comprehensive signal detection across geographies.
Immediate and Compounding Value
Immediate visibility into emerging patterns
Faster prioritization and investigation
Reduced exposure and complications
Lower cost and improved safety outcomes
Every earlier signal reduces downstream harm and cost.
Our Mission
To reduce preventable harm from medical devices by enabling earlier detection of emerging safety signals.
We measure success by how many patients are not exposed to harm.