Register for Cybersecurity Standards for Medical Devices
This course provides a general overview of current standards within cybersecurity for medical devices, and an overview of the cybersecurity requirements in the IVDR and MDR.
Cybersecurity standards and requirements
This course will provide you with a general understanding of cybersecurity risk management with regards to development process, product and organization according to the latest international standards and of the requirements in European regulations, such as the IVDR and MDR. After the course, you will also understand where the ISO 27000 standards fit in.
Topics
- Background – what sets medical devices apart?
- Requirements in the IVDR and MDR
- The cybersecurity standards landscape
- The new process lifecycle standard (81001-5-1)
- The new technical report with product requirements (60601-4-5)
- Introduction to FDA requirements and drafts
- Introduction to ISO 27000
- Summary
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