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
Skills to be acquired
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
Targeted audience
This course is intended for individuals or organizations involved in software within the medical device industry
Pedagogical, technical and framing means
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
Assessment specifics
- Questionnaire to assess the knowledge at the end of the training
- Customer survey
What is included ?
- Course materials, provided electronically
- Letter of attestation
- Official certificate
Do you need more information?
If you have any concerns, please do not hesitate to contact our service department on the following numbers:
Telephone: 01 89 79 00 40
Email: training.france@bsigroup.com Or via the webchat service on our website: bsigroup.com
You will be put in touch with our team if necessary.
