Module 14: Design Development and Certification of Medical Devices

22/11/2023

1. POST-MARKETING SURVEILLANCE ● Proactive – Customer surveys – Post-marketing clinical studies ● Reactive – Vigilance – Non-conformance reports CLINICAL DATA ..post-marketing surveillance

Masterclass: Lecture 12

The Organisation for Professionals in Regulatory Affairs

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PMS data

…any information about the device once it has been launched, including: • literature reviews, • patient registries, • customer complaints,

• customer surveys, • expert user groups, • user reaction during training programs, • media, trade shows, maintenance/service reports, • field evaluation, • retrieval studies on explants or trade-ins, • in-house testing, • failure analysis, AND…

POST MARKET CLINICAL FOLLOW-UP (PMCF) STUDIES.

Masterclass: Lecture 12

The Organisation for Professionals in Regulatory Affairs

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