Introduction to Medical Device Software Training Course - International

Niveau Comprendre Durée 1 journée de formation

Disponible pour réserver: Salle de classe virtuelle 1300€ + TVA Book now

This course is designed to provide you with knowledge of how the Medical Device Regulation (MDR (EU 2017/745)), standards and guidance documents impact medical device software; software as a medical device; and medical devices with software.

It will help you to understand how EN 62304 Medical device software - software lifecycle processes can improve your medical device software development, validation and lifecycle process.

Please note that this training will be held in English!

Prerequisites

You should have an awareness of Medical Device Regulations and knowledge of medical device software to benefit from this course.

Pedagogical objectives

Understand the key concepts and requirements of EN 62304
Gain knowledge of the implementation steps of the medical device software lifecycle processes
Correctly classify your medical device software as per the MDR
Perform the necessary risk management and software lifecycle management activities

This course is intended for individuals or organizations involved in software within the medical device industry.
On completion of this training, you’ll be able to:
- Define the medical device software terminology
- Identify the relevant standards, directives, and guidance documents
  recommended to develop, maintain and validate medical device software
- Determine if software is covered by an EU Medical Regulation for CE
  Marking
- Classify your medical software as per the MDR
- Apply concepts from the key software standards; including EN 62304
  (Medical device software - Software lifecycle processes), EN 60601-1
  (Medical Electrical Equipment and Systems) and from the MDR EU
  2017/745
- Evaluate software lifecycle processes and risk management to ensure they are compliant
- 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 program 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: Introduction to Medical Device Software - 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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