Cybersecurity - IT-Security for Medical Devices

Cyber Security

9/11/2024

Terms and regulatory requirements in the area of cybersecurity: MDR, FDA

Establishing a secure life cycle

Carry out threat modeling

Assessing security risks

Basics of secure design and secure development of secure software

Normative requirements and sources:

• MDCG 2019-16
• IEC 81001-5-1
• IEC TR 60601-4-5
• FDA QMS Guidance 2023
• FDA Postmarket Guidance

Practical tools:

• STRIDE
• CVE-DBs
• OWASP

Exercises

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