Clinical Research under MDR and ISO 14155:2020

A one-day intensive training about all related matters regarding clinical research aspects with medical devices, including a practical workshop.

 

CONTENT

  • Medical Device Regulation 2017/745 (MDR), MDCG documents, ISO 14155:2020, Declaration of Helsinki, GDPR
  • Submission to Ethic Committees, Competent Authorities
  • Conducting the clinical investigation, documentation, risk-based monitoring, informed consent
  • Safety in clinical investigations, reporting obligations, corrective actions
  • Noncompliance, Audits and Inspections, frequent problems
  • Workshop: development of a concept for a clinical investigation

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 Managing Director of Labquality’s subsidiary Artimed Medical Consulting GmbH in Germany.


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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