Content of-and Compliance to IEC 81001-5-1
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.”
The course is designed for various stakeholders within a medical device company:
- Security Specialist
- Quality Officer
- Process Owner
- Regulatory Affairs Officer
- Manager
- 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
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.”
Instructor-led in a virtual classroom.