The regulatory framework for cybersecurity (IT security) of medical devices is specified in the „General Safety and Performance Requirements“ section of the EU MDR and IVDR regulations. Standards and guidelines specify the requirements for implementation.
In this basic course, you will get an overview of the regulatory relevant standards and documents as well as field-tested tips, methods, tools and useful sources for the implementation of the requirements.
This basic course is also suitable for participants with no or little previous knowledge. For newcomer and start-ups, this course offers an optimal introduction to the topic of cybersecurity for medical device software.
This basic course is part of our online course: Medical Software Specialist!
Content:
- Meaning of key terms from the fields:
- Information Security
- IT Security and
- Operational Security
- Cybersecurity requirements for medical devices from
- applicable standards
- laws and
- guidance documents
- Tips, methods, tools and other useful resources for the implementation of the requirements