Risk management is pivotal issue of medical device law. In this seminar, you will learn to avoid making risk management errors resulting in audit issues and potentially delaying authorization of your medical product.
This seminar not only imparts comprehensive knowledge but also the skills needed to compile and assess risk management file for your medical devices and to coordinate activities of risk management.
The seminar lasts two days. Practical relevance is paramount. The lectures are alternating with case studies and several exercises. We are pleased to even discuss specific files and subject them to a "Quick-Check".
|09:30||Relevant standards, laws, regulations, other guidelines and their interactions|
|11:30||Risk policy, risk acceptance matrix|
|13:00||Case study "compiling a risk acceptance matrix"|
|14:45||Approaches to risk analysis (FMEA, FTA, PHA)|
|15:45||Case study "hazard and risk analysis"|
|16:45||Summary and Q&A|
|09:00||Updating expectations, answering unresolved questions|
|09:30||Risk mitigation, measures, safety-critical architecture|
|10:45||Risk management along the product life-cycle development and market surveillance (vigilance and reporting system)|
|13:00||Case study "risk management and post-market surveillance"|
|14:45||Special topics: special considerations concerning software, review of sample files|
|16:15||Exam (participation is optional)|
|16:45||Closing of the seminar|
We limit the maximum number of participants to 16 to ensure learning success and having enough time to respond to individual questions.
The seminar addresses everyone involved in software development for medical devices complaint with standards, especially
The seminar is also suited for beginners and (also) imparts the foundations of risk management. However, over the course of this intensive workshop, participants reach an advanced level and deal with demanding tasks.
Do you have any questions or suggestions? Do you want to carry out the seminar as an inhouse seminar to tailor the topics to your individual needs? Contact us directly. We are looking forward to it!