gempex WebSeminar: PMCF – Generating EU MDR Compliant Clinical Data

PMCF studies as a tool for generating clinical data.
Register now!


Wednesday, 13 October 2021 - DE

 

Wednesday, 20 October 2021 - EN

 


WebSeminar - alternatively in German and in English.
Participation is free of charge.

  • Basics
  • Introduction to the topic PMCF
  • In the follow-up: discussion of individual PMCF plans, questions, assistance.

Clinical data, clinical studies, clinical evidence - one of the most burning issues of the EU MDR. Stricter requirements apply with regard to scope and quality. Manufacturers of medical devices are required to systematically collect and evaluate clinical data both before and after product approval.

What possibilities are there to fulfill this requirement?
Can the enormous effort of a clinical study be avoided or reduced?

The gempex WebSeminar PMCF – generate EU MDR Compliant Clinical Data 
provides a compact overview of the basics and innovations. 

The tool of PMCF studies is presented: methodology, approach, advantages.
How can users, physicians, clinics be brought in for clinical follow-up?

Participants will receive a template to use their own data to apply what they have learned and create their own PMCF plan.
The  opportunity for individual discussion is offered in the follow-up, further processing, answering questions, providing assistance.

 

Target Group
The WebSeminar addresses to 

  • Legal manufacturer for medical devices
  • Contract Manufacturer
  • Contract Developer

Learning Objectives
Basics
- How are clinical data defined in the EU MDR?
- Where do you get clinical data for your product?
- What are the options if the existing clinical data are not sufficient to evaluate the product?

 PMCF Study
- What is a PMCF study?
- How can this be built up?
- Flow Chart, approach
- What is needed?
- Template 

Speakers

Philipp Stockmann, Senior Consultant, gempex GmbH
Maren Wiese, Senior Consultant, gempex GmbH 

 

Register now!
The WebSeminar is offered in both languages, German as well as in English.

Thursday, 13 October 2021, 10-11 a.m. - German

Thursday, 20 October 2021, 10-11 a.m. - English

 

For questions, please contact Joachim Paap, Senior Manager Medical Devices, via Joachim.Paap@gempex.com.