Risk management is the linchpin of medical device law. In this workshop, you will learn to avoid risk management mistakes that can lead to problems in audits and delays in the "approval" of your medical devices.
This seminar thus provides you not only with a comprehensive knowledge, but also with the skills to create and review the risk management files for your medical devices and to coordinate the activities related to risk management.
The seminar lasts two days, with a focus on practical relevance. The lectures alternate with case studies and numerous exercises. We are happy to discuss your specific files and subject them to a "quick check" if desired.
|09:30||Relevant standards, laws, directives, regulations and other requirements and their context.|
|10:45||Definitions of terms|
|11:30||Risk evaluation, Risk acceptance matrix|
|13:00||Case Study "Creating a Risk Acceptance Matrix"|
|14:45||Methods for hazard analysis (FMEA, FTA, PHA)|
|15:45||Case study “Hazard and risk analysis”|
|16:45||Summary and answering questions|
|17:00||End of day 1|
|09:00||Updating expectations, answering open questions|
|09:30||Risk control: measures, safety-critical architectures|
|10:45||Risikomanagement im Produktlebenszyklus: development & post market surveillance (vigilance and reporting system)|
|13:00||Case study „Risk control and post market observation“|
|14:45||Special topics: Special features of software, review of sample files|
|16:15||Exam (participation optional)|
|17:00||End of seminar|
The seminar is intended for persons involved in the development of medical devices in compliance with standards, in particular for
The seminar is also suitable for beginners and teaches (also) the basics of risk management. However, in the course of this intensive workshop, participants reach a higher advanced level and work on challenging tasks.