Lifecycle risk intelligence
Medical device issues rarely appear suddenly. They emerge as weak signals over time — and current systems detect them too late. RP360 exists to close that gap.
≈7.6 months
of patient exposure removed — 85% of the window between when the mechanism becomes detectable and when the recall is finally written.
Volume-based surveillance· what happens today
Recall issued 9 months after the first signal — patients are exposed for that whole span.
RP360· mechanism-based detection
Detected at 6 weeks — while the corrective action still changes the outcome.
With the recall issued 9 months after the first signal and RP360 detecting the mechanism at 6 weeks, about 7.6 months of patient exposure is removed — 85% of the window.
01 / What we build
Every part of RP360 serves the same goal — helping medical device teams move from reactive compliance to predicting risk earlier.
Predict
Enterprise risk intelligence for medical device manufacturers. Identify emerging risk earlier, prioritize what matters, and act with confidence.
Learn
Expert-led education across regulatory, quality, risk and post-market intelligence — free foundational courses, certifications, exam prep, and deep learning tracks.
Create
Turning dense technical and regulatory material into clear, consistent video — so knowledge reaches the people who need it, at the pace the work demands.
02 / The platform
Enterprise risk intelligence for medical device manufacturers — collecting data, detecting patterns, scoring risk, and driving clear next steps.
Step 01
Collect data from internal & external sources.
Step 02
AI/ML detects patterns and emerging signals.
Step 03
Risk scoring and prioritization.
Step 04
Drives decisions and prevents harm.
03 / Why earlier
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 Academy
The Academy is an expert-led learning platform for medical device professionals, spanning regulatory affairs, quality systems, risk & safety, and post-market intelligence.
Tracks
Regulatory Affairs · Quality Systems · Risk & Safety · Post Market Intelligence
Exam prep
Exam-aligned simulator with a rationale on every answer
Free foundational courses — no payment required to start.
05 / Studio
Our third capability is in development. The goal is the same as everything else we build: get the right knowledge to the right people faster — this time by turning dense technical and regulatory material into clear, consistent video.
Still early. If it's relevant to your team,tell us what you'd want from it.
06 / Who it's for
Medical device manufacturers — particularly quality, regulatory, post-market surveillance and risk management teams — that need to detect risk earlier across a device portfolio and support decisions with evidence.
Request a demo
Don't wait for signals to become problems.
