POST MARKET
SURVEILLANCE
SYSTEM AUDIT

POST MARKET
CLINICAL
FOLLOW UP

PERIODIC
SAFETY USER
REPORT

POST MARKET
SURVEILLANCE
TOOLS

POST MARKET
SURVEILLANCE
PLANS

POST MARKET
SURVEILLANCE
PLANS

PRIORITY
ONE

TRANSITION SUPPORT
 
 

EU MDR
POST MARKET
SURVEILLANCE CONSULTING

PMS CONSULTING SERVICE OPTIONS

COMPANION SERVICES

PARTNER SERVICES

ALLY SERVICES

PMS SYSTEM AUDIT

Gap assessment:

Review Current Post Market Policy
against EU MDR Post Market requirement to identify potential gaps – Chapter VII, Section I Article 83 EU Medical Device Regulation (EU) 2017/745

PMS STRATEGY

Compliance Strategy:

– Review Client QMS
– Review Client EU MDR roadmap
– Product Portfolio Analysis
– Develop Strategic PMS Policy

PMS PLANS

Standard Operating Procedures:

– PMS Procedure
– PMS Plan Template
– PMS Report Template
– PSUR Procedure
– PSUR Template
– PMCF Procedure
– Summary of Safety Procedure
– Clinical Performance Procedure

PMS TOOLS

PMS Process Optimization Tools:

– Customer Feedback Tool Selection
– Electronic Data Capture System for Post Market Clinical Follow-up
– Search Tools for similar product experience
– Clinical Literature Database Selection

PSUR

Report Writing:

– Safety signal identification
– Clinical Literature review
– Comprehensive Risk Benefit Analysis
– PSUR submission

 

PMCF

Clinical Research:

– PMCF Study Design
– PMCF Protocol Development
– PMCF Registry Selection
– PMCF Study Implementation
– PMCF Data Analysis