Proactive Post Market Surveillance Analysis

Q4-2024 to Q3-2025 Clinical Performance Assessment

Therapy Outcome Distribution

Therapy Objective Breakdown

Clinical Observations by Device

Clinical Observations by Quarter

100%
Success Rate
Total Observations
Critical Care Focus
Device 3880 Usage

📊 Temporal Pattern Analysis

📈 Key Performance Indicators

100%
Therapeutic Success
0
Adverse Events
2.2:1
3880:3860 Ratio
39.5
Avg. Observations/Quarter

📋 Strategic Recommendations

Maintain Excellence: Continue current clinical protocols to sustain the 100% success rate.
Capacity Planning: Prepare for Q4 demand surge through resource allocation.
Device Optimization: Leverage 3880 platform dominance for standardization while maintaining 3860 specialty capabilities.

Proactive Post Market Surveillance Analysis

Q4-2024 to Q3-2025 Clinical Performance Assessment

🎯 Clinical Performance

Success Rate:The existing data are sufficient to verify that the device is in conformity with all the essential requirements pertaining to clinical performance, clinical safety and undesirable side-effects as there were no statistically significant increases in the frequency or severity of complaints.

🔵 Device 3880: Primary Platform

- 100% success rate demostrated a consistent clinical performance and proven reliability in diverse therapeutic scenarios.

🟢 Device 3860: Specialized Applications

- 100% success rate demostrated a consistent clinical performance and proven reliability in diverse therapeutic scenarios.

📊 Temporal Pattern Analysis

📈 Key Performance Indicators

100%
Therapeutic Success
0
Adverse Events
2.2:1
3880:3860 Ratio
39.5
Avg. Observations/Quarter