Content
Implementing cybersecurity means applying technologies, processes and controls to protect systems, networks, programs, devices and data from cyberattacks.
In the seminar, an introduction to the topic will be given and cybersecurity lifecycle management will be presented. The focus is on the integration of cybersecurity-related activities, required by IEC 81001-5-1, in the software life cycle processes according to EN 62304. A look at the FDA requirements and their guidance rounds off the training.
Topic overview
- Introduction, terms and definitions
- Overview of the regulatory requirements for cybersecurity in medical technology
- Presentation of a cybersecurity lifecycle management model
- Explanation of the requirements of IEC 81001-5-1 for IT security-related activities in the product life cycle
- Integration of these activities into the software life cycle process according to EN 62304
- Safety & Security Risk Management according to EN ISO 14971 and AMII TIR 57
- Exemplary procedures and practical exercises
target group
(Software) development managers as well as software architects and developers, but also employees from regulatory affairs, quality and process management.
Prior knowledge
Basic knowledge of the product life cycle, development cycle and especially software life cycle processes of medical devices and the relevant processes.
Funding opportunity
ESF funding is possible. Further information can be viewed here .
Early bird discount
If you register up to 3 weeks before the start of the seminar, you will receive an early bird discount of 10 percent.
KONTAKT:
Online
