Reactive Monitoring is Risky Business
Waiting for a patient injury or serious incident to report a problem is no longer an acceptable practice. Global regulators, led by the EU MDR, now demand proactive and continuous surveillance of device performance in the field.
The Data Silo
Customer complaints and feedback get trapped in commercial departments and never reach the engineering or quality teams who can act on them.
MDR Fatigue
The massive documentation burden of EU MDR, including Periodic Safety Update Reports (PSUR), overwhelms already-stretched teams.
Disconnected Risk
Failing to update the ISO 14971 Risk Management File with real-world failure rates, leaving a critical gap for auditors to find.
The Leanabl Insight
Effective Post-Market Surveillance is the "Check" phase of the Plan-Do-Check-Act (PDCA) quality cycle. We close the loop by ensuring real-world market data is systematically fed back into your Design Controls and Risk Management processes.
Total Vigilance & Reporting
We manage the entire spectrum of post-market activities, from daily complaint handling and adverse event reporting to the creation of annual regulatory reports.
Strategic PMS Planning & PMCF
We develop robust PMS plans and execute Post-Market Clinical Follow-up (PMCF) activities like surveys, literature reviews, and formal studies to meet EU MDR requirements.
Complaint Handling & Vigilance
Our team manages the entire vigilance process: from complaint intake and triage to global incident reporting (MDR MIR, FDA 3500A, Korean Adverse Events).
Aggregate Reporting (PSUR/PBRER)
We author comprehensive Periodic Safety Update Reports (PSUR) for Class IIa, IIb, and III devices, including trend analysis and benefit-risk re-evaluation.
The Closed-Loop Quality System
We ensure the voice of the patient reaches the engineer's desk.
Collection & Triage
Action & Update
Analysis & Investigation
Your Continuous Compliance Engine
PMS Plan & Report
Annual strategic documents and summary reports.
Vigilance Reporting
Timely and compliant adverse event submissions.
Trend Analysis Dashboard
Visual tracking of key performance and failure modes.
Why Outsource PMS to Us?
EU MDR Experts
We are specialists in the nuances of MDR 2017/745, particularly the demanding requirements for Post-Market Clinical Follow-up (PMCF) and PSUR authoring.
Risk Integration
We go beyond simple reporting to mathematically recalculate the "Probability of Occurrence" for harms in your risk file based on real-world field data.
Global Coverage
We serve as your single partner for vigilance and reporting across key global agencies, including the FDA, EU Competent Authorities, and the Korean MFDS.
Listen to Your Data.
Transform post-market feedback from a compliance burden into your next competitive advantage.
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