Webinar

Free Webinar | Effectively Managing Clinical Data Collection Using Cost-Sensitive Methods – PMCF Surveys 

June 21, 2022

Date21 June 2022

Time: 16:00 - 17:00 CEST/10:00 - 11:00 AM EST  

Location: Virtual

Introduction

Manufacturers are finding that they do not have clinical data on their own devices, as required by the EU MDR. So they are turning to PMCF surveys as a cheap and easy way to gather the required data. Although PMCF surveys can be a valuable tool to collect clinical data on your own device using a PMCF survey will only work when it is designed to meet both regulatory requirements and appropriate objectives.

During the first part of this session, lessons learned from planning, execution, reporting and notified body review of PMCF surveys will ben discussed. In the second part of the session will be on how to apply these lessons learned. This includes scoping and definition of endpoints and acceptance criteria of the survey.

Learning Objectives

  • Understand the impact of lessons learned on PMCF surveys
  • Design a PMCF survey that can be used to collect clinical data on your device

Trainer:

Bianca Lutters
Post date: May 18, 2022
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