IN ONE SIMPLE SENTENCE
Ongoing monitoring after market entry to identify problems, trends and new information about safety and performance.
What is this service?
Work does not end when the device is approved and sold. PMS systematically collects real-world information to understand how the device performs after market entry and whether new problems emerge.
GOAL
Detect problems, unfavorable trends and changes in the benefit-risk profile as early as possible during real-world use.
What can MICT do here?
Design the PMS plan, consolidate complaint/service/feedback/literature/post-market data, analyze trends and prepare periodic outputs.
TYPICAL INPUTS
What we usually need to start
- Customer complaints
- Service and repair records
- Hospital and user feedback
- Incidents and events
- PMCF and new literature
- Sales volume or number of uses
TYPICAL OUTPUTS
What this stage can deliver
- PMS plan
- Trend analysis
- PMS report
- Signal list
- Recommendations for CAPA or further PMCF
- Inputs to CER and risk-management updates
Important terms in plain language
PMS
Planned surveillance of a device after it enters the market.
Signal
A finding that may indicate a new problem or risk and requires evaluation.
Trend
A change in a measure over time, such as a gradual rise in complaints.
CAPA
Corrective and Preventive Action used to address a problem and reduce recurrence.
Benefit-Risk
The balance between the benefits of the device and its risks.
SIMPLE EXAMPLE — BLOOD PRESSURE MONITOR
If measurement-error complaints for a blood-pressure monitor rise for three consecutive months, PMS should detect and investigate the trend.