1-day course, online

Topics

• Background – what sets medical devices apart?
• Requirements in the IVDR and MDR.
• The cybersecurity standards landscape.
• The new process lifecycle standard.
• The new technical report with product requirements.
• Introduction to FDA requirements and drafts.
• Introduction to ISO 27000.
• Summary.

Educational goals

After the course, participants will have 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. Participants will also understand where the ISO 27000 standards fit in.

Recommended prior knowledge

A basic knowledge of risk management according to ISO 14971. A basic knowledge of IT security.

Course Leader

Krishnadev Moothandassery Ramdevan, Senior Quality and Regulatory Consultant