Risk Management for Cybersecurity acc. to the MDR

Medical device

10/14/2021

• Norms, standards and guidance
• IEC TR 60601-4-5:2021
• IEC 81001-5-1:2020
• ISO 27005:2018
• IEC 62304 and IEC 82304-1
• BSI 200-3
• AAMI TIR 57:2016
• ISO/TR 24971:2020
• FDA Cybersecurity Guidance
• Threat modelling (STRIDE) with practical exercises
• Cryptography
• CIA Triade
• Vulnerabilities from CVE and CVSS
• Risk management plan
• Risk evaluation
• Risk report
• Change management
• Security by Design
• Security during the whole lifecycle

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