Clinical Evaluation for Medical Devices - International Training

Niveau Spécialiste Durée 1 journée de formation

Disponible pour réserver: Salle de classe virtuelle 950€ + TVA View dates and book your training

This one-day course offers a robust overview of the clinical evaluation process for medical devices against the medical device regulation (MDR - EU 2017/745), MEDDEV 2.7/1 revision 4 and relevant MDCG guidance documents.

Designed for clinical professionals with a base understanding of general safety and performance requirements, this training teaches you how to explain the key principles of clinical evaluation. During this stage of your learning journey, you will gain skills to determine when your device requires clinical investigation, and you will leave with a full grasp of the clinical evaluation process.

Please note that this training will be held in English!

Prerequisites

Familiarity with your own device, clinical safety and performance issues.

Awareness of:

General Safety and Performance Requirements (Annex I), Clinical Evaluation and investigations (Annex XIV and XV) of the MDR - EU 2017/745

MEDDEV 2.7.1 Revision 4 and relevant MDCG guidance documents

Pedagogical objectives

Fully grasp clinical evaluation requirements in line with the Medical Device Regulation (MDR - EU 2017/745), MEDDEV 2.7/1 revision 4 and relevant MDCG guidance documents
Able to explain key requirements and expectations of medical device clinical evaluation to your organization
Apply the clinical evaluation process for medical devices within your organization

Clinical and Regulatory Affairs Professionals, Medical Device R&D Engineers and Scientists.
Upon completion of this training, you will be able to:
- Identify the key requirements for clinical evaluation according to the MDR, MEDDEV 2.7/1 Revision 4 and relevant MDCG guidance documents
- Explain the principles of clinical evaluation
- Outline the stages of the clinical evaluation process and documentation requirements
- Define how clinical evaluation is performed, including details on clinical evaluation plans (CEP), demonstration of equivalence, identification and appraisal of data and analysis of clinical data
- Determine when a clinical investigation is needed for your device
- Explain the post-market clinical follow-up (PMCF) requirements
- Define the requirements of a clinical evaluation report (CER)
- Questionnaire to assess the knowledge at the end of the training
- Customer survey
- Course materials, provided electronically
- Letter of attestation
- Official certificate
Course materials including :
- Introduction to the training, detailed programme and security assignments
- Course presentation, theory and activities/ role plays
- Answers to the activities
- Videos
- Additional documents, distributed during the sessions, to use for the activities
- Attendance sheet to be signed
This guide will give you all the necessary information.
Download our training guide: Clinical Evaluation for Medical Devices - International
* These training modules are eligible to the subsidizing by the public institutions in France (OPCO).

**Each delegate receives a training convention after enrollment.

***Please note that for the public sessions, you have until 48h before the start of the course to confirm your enrollment. For the in-house sessions, the deadline would be of two weeks prior to the start of the course.

****Should you be in a disabled situation, please contact us and indicate what details should be taken into account.

You can contact us on training.france@bsigroup.com or 01 89 79 00 40.

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