Content of and Compliance to IEC 81001-5-1
Participants who successfully complete this training will:
- Learn about the key points of IEC 81001-5-1.
- Get to know the point of view of a notified body.
- Acquire a deeper understanding of IEC 81001-5-1.
- Be enabled to operate in and create compliant security processes.
The course is designed for various stakeholders within a medical device company:
- Security Specialist
- Quality Officer
- Process Owner
- Regulatory Affairs Officer
- Manager
The issue of cybersecurity is a special concern for a number of industries, including the medical device industry. Quality healthcare depends on secure access to advanced medical technologies that use software and communications protocols to actively exchange vital patient information with other medical systems and devices. Cyber breaches impacting medical devices not only put the safety of individual patients at risk, but also severely compromises the quality of healthcare for people worldwide.
To help address the growing challenges of software-related cybersecurity concerns linked to medical devices, the International Electrotechnical Commission (IEC) has published IEC 81001-5-1, “Health software and health IT system safety, effectiveness and security—Part 5-1: Security—Activities in the product life cycle.”
This course will provide you with key knowledge behind the upcoming harmonized process standard IEC81001-5-1 for medical device cyber security.
- Introduction & Motivation
- 81001-5-1 vs SDL vs MDCG 2019-16 vs UL2900-3-n
- Cl. 4 General
- Cl. 5 Software Development Process
- Cl. 6 Software Maintenance Process
- Cl. 7 Security Risk Management Process
- Cl. 9 Software Problem Resolution Process
- Conclusion
- Course delivered by one of TÜV SÜD's leading industry experts
- Small class sizes enhance trainer-delegate relationship
- Receive globally recognised TÜV SÜD certificate upon completion
Upon completion you will receive your globally recognised TÜV SÜD certificate of attendance on Content of and Compliance to IEC 81001-5-1.
Successful completion of the foundation level “Medical Devices / In-Vitro Diagnostics Cyber Security Basic Training".