This seminar provides you with comprehensive knowledge of risk management and the competence to coordinate all your company's risk management activities and create compliant risk management files for your medical devices.
Among other things, you will learn how to define comprehensible risk acceptance criteria, systematically identify hazards, evaluate risks, and define suitable measures for risk control. Our expert will show you how to compile all this information quickly and compactly in your risk management file and check it for compliance.
The many examples from Christian Rosenzweig's wealth of experience and his extremely broad overview of the topic were impressive.
In contrast to a purely theoretical lecture, our trainer uses practical exercises and sample documents to help you transfer what you have learned directly into your everyday work and onto your devices. Instead of clinging to rigid plans and examples of little relevance, he explains the material using real devices and addresses your specific case.
Unlike typical inspectors, our trainer does not just point out mistakes but uses his own daily work to teach you the best practices for creating precise and compliant risk management files. In this seminar, you will receive concrete guidance and precise answers to your questions so that you can pass your future audits and reviews successfully.
There is a voluntary online exam at the end of the seminar (duration: approx. 20 min). By passing this exam, you will receive a certificate proving your newly acquired knowledge and skills in addition to your attendance confirmation.
Phone
+49 7531 94500 20
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The seminar covers the following topics:
After the seminar, you will be able to:
This seminar is designed for people who will (in the future) take on one or more of the following roles:
Participants can follow this seminar well even without any special prior knowledge.
Understanding their own medical devices is helpful.
After registering, you will receive a confirmation email containing the meeting link, the time, and information about the participants.
An invoice will be sent to you within the next 48 hours, with a payment term of 14 days. If this payment term is not feasible for your company, please send a short e-mail to [email protected] to find a solution.
Three days before our online seminars and workshops, you will receive two e-mails: The first contains the final link to the seminar and the second contains the access data to a cloud folder in which you will find documents for preparation, exercises, and presentations.
If the seminar or workshop takes place in person, you will also receive the access link to your seminar documents three days before the date of the event. We will also provide documents in digital form for in-person events.
The seminar takes place either in person or online.
Our online/remote seminars and workshops are conducted via the video conferencing tool MS Teams. We recommend dialing in 20 minutes before the seminar begins so that any technical problems can be resolved in good time. If you have any questions or encounter any issues, our team is always available to help.
We also recommend that you arrive at the seminar room approximately 20 minutes before the start of the face-to-face events.
At the end of the seminar, you will receive a feedback link for evaluation. The following day, we will send you your certificate of attendance.
If you experience technical problems while participating or have any other questions, you can contact our support team anytime, even at short notice. The documents provided also include an emergency number to help you in urgent cases.
Our general FAQ section answers further technical and organizational questions.
As an engineer for biomedical technology, Christian Rosenzweig was responsible for basic and software development for complex active medical devices for many years. As the person responsible for carrying out and guiding conformity assessment procedures in the EU and USA, he gained experience with all forms of audits and various markets (in particular, FDA and MDSAP). He was also an ISO 13485 quality management representative in a large corporation. As a sought-after expert, he assists our customers with strategy issues and the implementation of quality or regulatory affairs management. His focus is on the safety of medical devices, risk management, and IT security.
We are also happy to offer our seminars, courses, and workshops in-house. Depending on your needs, these can be held online or at your premises.
Please feel free to contact us.
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