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.
Who Should Attend?
The course is designed for various stakeholders within a medical device company:
- Security Specialist
- Quality Officer
- Process Owner
- Regulatory Affairs Officer
- Manager
Course Agenda
- 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 Description
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.”
Benefits
This course will provide you with key knowledge behind the upcoming harmonized process standard IEC81001-5-1 for medical device cyber security.
Methodology
Instructor-led training in a virtual classroom. This means the course is Live Online. Participants will learn through online teaching. Lectures, case studies, group exercises, discussions, problem solving, examples with explanation, assignments and/or quizzes happen in the virtual classroom training. Participants need to connect to the class from any internet accessible location. Each module is delivered live using webinar technology, creating a virtual classroom learning environment. Live sessions provide you with direct access to the trainer so you can ask questions, understand complex concepts and share ideas with peers. Webcam and microphone are REQUIRED to interact with the instructor and/or other participants.
The course content and structure are designed by the domain experts from TÜV SÜD.
With immense experience and knowledge in the relevant standards, our team of product specialists and technical experts at TÜV SÜD, developed the course content based on current business landscape and market requirements.