Module 15 Presentations
10/04/2024
PMS and PMCF data sources
The Organisation for Professionals in Regulatory Affairs
Module 15 Lecture 6
15
PMS and PMCF data sources
CLINICAL EVALUATION FEEDBACK SYSTEMS
POST-MARKET CLINICAL FOLLOW-UP PLAN Annex XIV, Part B, 6 / MDCG 2020-7
POST-MARKET SURVEILLANCE PLAN Article 84
Complaints
Literature searches
Vigilance
Recalls or other regulatory information
Proactive surveys (user satisfaction)
PMCF investigations
Service or maintenance reports
Sales and marketing intelligence
CORRECTIVE AND PREVENTATIVE ACTION
The Organisation for Professionals in Regulatory Affairs
Module 15 Lecture 6
16
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