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.
How will I benefit?
This course will help you to:
- 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
Who should attend?
This course is intended for individuals or organizations involved in software within the medical device industry.
What will I learn?
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 post- market surveillance and vigilance
What is included?
- Course information
- Dinner
- Coffee break
You’ll be awarded an internationally recognized BSI Training Academy certificate.