Clinical evaluation of medical devices according to MDR & MEDDEV 2.7/1 Rev. 4

A one-day intensive training about all related matters regarding the preparation of a clinical evaluation for a medical device including a workshop.

 

CONTENT

  • Medical Device Regulation 2017/745 (MDR), MDCG documents, MEDDEV 2.7/1 rev. 4
  • Basics of clinical evaluation, clinical data, the relationship between PMS/PMCF and clinical evaluation (CEP, CER)
  • Structure and content of a CEP and CER, clinical evaluation process, required documents and data, equivalent, similar and benchmark devices
  • Different ways of clinical evaluation, evidence-based medicine, different types of scientific publications, dealing with problematic data, problem areas: too much or too little clinical data
  • PMS and PMCF, CAPA, clinical evaluation update, risk/benefit ratio
  • Clinical evaluation workshop: Literature research, evaluation of literature, dealing with problem areas

Target audience:
People working in clinical research, safety reporting, regulatory affairs, and quality management.

After the training:

  • you are familiar with the specific regulatory requirements for clinical investigations with medical devices
  • you can develop a clinical investigation plan and synopsis
  • you know which ethical, scientific and quality aspects need to be considered
  • you will learn in a workshop which problems may arise and how they can be solved
  • you will be able to plan, conduct and evaluate a clinical investigation with a medical device and understand the relevant regulatory requirements

Trainer:

Markus Hahn, MD, MScPM, has been working in clinical research since 1997. He is the team lead for Labquality’s subsidiary Artimed Medical Consulting GmbH in Germany.

Kirsten Sander, MSc Biology, is the Clinical Research Team Lead for Labquality’s subsidiary Artimed Medical Consulting GmbH in Germany. She has been working in clinical research for more than 10 years.


Duration:
One day

Place: Online
Language: English


BILLING AND CANCELLATION POLICY 
Participation in the training can be cancelled two weeks (14 days) before the event free of charge. For cancellations made after this, we will charge 50% of the participation fee, except for cancellations made one week before the event, we will charge a 100% participation fee.

Cancellations are always made in writing to: koulutus@labquality.fi.  
The participating organization may, if it wishes, change the participant free of charge by notifying it in writing before the event to: koulutus@labquality.fi. The participation fee will be invoiced immediately after the event. The training session will be confirmed to the participant by e-mail about a week before the event.  Labquality reserves the right to cancel the training session due to a small number of participants.

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