PMCF in accordance with MDR and MDCG

A half-day intensive training about all related matters regarding post-market clinical follow-up activities with medical devices.

CONTENT

  • Medical Device Regulation 2017/745 (MDR), MDCG documents, ISO 14155:2020, Declaration of Helsinki, GDPR
  • Basics of clinical evaluation, clinical data, the relationship between PMCF and clinical evaluation (CEP, CER), legal requirements for PMCF activities
  • Different possibilities of PMCF measures, PMCF plan, PMCF report, PMCF and inventory products, PMCF and new product development

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 post-market clinical follow-up activities with medical devices
  • you can develop a PMCF plan and synopsis
  • you are familiar with the different options which exist in terms of PMCF measures
  • you know which ethical, scientific and quality aspects need to be considered
  • you will be able to plan, conduct and evaluate post-market clinical follow-up activities and understand the different options

Trainer:

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


Duration:
Half 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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