Medical Device Software with Cybersecurity Training Course - International

Niveau Spécialiste Durée 1 journée de formation

Disponible pour réserver: Salle de classe virtuelle 950€ + TVA Request a date

This course is designed to provide you with the knowledge to appropriately address the medical device software cybersecurity requirements of the MDR 2017/45 and related MDCG guidance documents.

You will also gain knowledge on performing the necessary risk and software lifecycle management activities in order to mitigate cybersecurity risks.

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 of cybersecurity for medical device
software
Gain knowledge of the cybersecurity requirements of the MDR 2017/45
and related MDCG guidance documents
Appreciate the lifecycle stages of secure design and manufacture for
medical device software
Gain awareness of the post-market surveillance and vigilance
requirements related to cybersecurity incidents/vulnerabilities

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 cybersecurity terminology related to medical device software
- Identify the key concepts of medical device software cybersecurity
- Apply the cybersecurity requirements of the MDR 2017/45 and related
  MDCG guidance documents
- Develop a secure design and manufacturing process for medical device software
- Prepare the appropriate documentation specific to security requirements
- Appropriately manage cybersecurity incidents and vulnerabilities via postmarket surveillance and vigilance
- Course materials, provided electronically
- Letter of attestation
- Official certificate
Assessment specifics
- Questionnaire to assess the knowledge at the end of the training
- Customer survey
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: Medical Device Software with Cybersecurity
* 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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