This 1-day course on Cybersecurity standards for medical devices is designed to help professionals gain an understanding of the current standards within cybersecurity for medical devices and an overview of the cybersecurity requirements in the IVDR and MDR.
📅 Next session: Online, 27 May 2026 (held in English)
🕘 Time: 08:30 – 16:00 CET
💰 Price: 8600 SEK (excl. VAT)
Are you a quality or regulatory professional, software developer, or IT manager who needs to create a structured system for cybersecurity product risk management? This course will equip you with an understanding of cybersecurity risk management with regards to development process, product and organization, according to the latest international standards and the requirements in European regulations such as IVDR & MDR.
This course covers:
The cybersecurity standards landscape, including requirements in the IVDR & MDR
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
The course is held in English and led by Krishnadev Moothandassery Ramdevan, Senior Quality & Regulatory Consultant.
Learn more and register