Cybersecurity - IT security for medical devices

• You will be familiar with the regulatory requirements for cybersecurity.
• You will learn about the various normative requirements and applicable documents relating to information security.
• You will learn how to establish cybersecurity throughout the life cycle of your medical device

Terms and regulatory requirements in the areaof 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, e.g.MDCG 2019-16, IEC 81001-5-1 , IEC TR60601-4-5, FDA QMS Guidance 2023, FDAPostmarket Guidance
• Practical tools e.g. STRIDE, CVE-DBs,OWASP
• Exercises

Certificate of attendance from TÜV SÜD Academy

Medical device manufacturers whose productscontain software or are a stand-alone softwareproduct from the areas of

• Security at medical device manufacturers
• regulatory affairs
• quality management
• System and software engineering
• requirements engineering- project management
• Risk management
• product management
• Management- Service provider/supplier in medicaltechnology
• Consultants for medical software
• Employeesfrom suppliers who are planning to enter themedical device industry
• Consultants in the medical device industry

 All online sessions for this event are run by TÜV SÜD Akademie GmbH in Germany. For online training courses, the General Terms and Conditions, examination regulations and data protection information of TÜV SÜD Akademie GmbH therefore also apply. If you have any queries, please do not hesitate to contact us at [email protected].