In this seminar, you will learn about the requirements of ISO 15189, ISO 22367, and IVDR Annex I for risk management and how to implement them in your laboratory with the help of practical exercises and best practices.
After the seminar, you will be able to create compliant risk management files that not only withstand DAkkS audits but are also compliant with Annex I of the IVDR.
Avoid non-conformities during inspections by authorities and DAkkS audits. Our practice-oriented seminar shows you how to successfully combine Rili-BÄK, ISO 15189, ISO 22367, and IVDR Annex I. Using concrete examples from laboratory practice, you will learn how to create compliant risk management files that will pass any review.
The risk management seminar was practical, well-structured, and tailored to our individual needs. The speaker was extremely well-prepared, addressed our existing processes in a targeted manner, conveyed the content clearly, and was able to answer all questions competently. A very successful seminar.
Put an end to time-consuming research and unclear requirements. In our seminar, you will learn how to systematically identify hazards in the laboratory, estimate risks, and define effective measures through practical exercises and best practices. 100% of our participants recommend us to others – you too can benefit from our expertise!
We are the only seminar on the market that combines the requirements of Annex I of the IVDR with ISO 15189 and ISO 22367. You will learn about the requirements for risk management for in-house IVD in detail and how these differ from those for CE-IVD. That will enable you to create legally compliant risk management files for your laboratory-developed tests from now on.
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.
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+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:
Participants can easily follow this seminar even without any special prior knowledge. An understanding of one's own examination procedures, in particular one's own in-house IVD, 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.
Dr. Sophie Bartsch is a biologist and worked as a research assistant in an accredited diagnostic laboratory for three years after completing her doctorate. In addition to routine diagnostics, she was responsible for establishing NGS-based workflows, among other things. She then worked as a laboratory manager responsible for developing a molecular biology assay with machine learning-based evaluation software. At the Johner Institute, she supports our customers in approving IVD medical devices. She focuses on strategic product alignment and the device-specific creation of technical documentation.
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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