This practical seminar will help you carry out the systematic literature search required by the IVDR in a structured and efficient manner and document it comprehensibly. It will enable you to demonstrate the state of the art for your IVD medical device and to prove the scientific validity of an analyte or software output.
First, you will gain an overview of the regulatory requirements for the state of the art and scientific validity.
Our expert will then show you:
The seminar on literature research, state of the art, and scientific validity was extremely informative and practical. The concrete examples and interactive format made it much easier to understand. The training was very helpful, and we gained valuable insights.
The seminar combines short presentations with practical exercises, during which our experienced expert will provide you with valuable tips. By the end of the seminar, you will be able to select suitable data sources for your specific question, systematically derive search terms, and conduct and document your literature search in a reproducible manner.
You will receive our tried-and-tested templates for the SOTA report, the scientific validity report, and the literature search protocol. That gives you all the tools you need to document your systematic literature search to determine the state of the art and prove scientific validity in a manner that complies with regulatory requirements.
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:
This seminar is designed for:
Participants can easily follow this seminar, even without any special prior knowledge. Understanding your own 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.
Dr. Juliane Havlicek is a biotechnologist with many years of industry experience with IVD medical device manufacturers. As team leader, she developed various in vitro diagnostic tests (IVD). She focused on the device-specific implementation of the design control process and the verification and validation of assays and devices. As an expert in IVD medical devices and performance evaluation, she supports Johner Institute customers in preparing technical documentation. Her expertise lies in development documentation, risk management, and performance evaluation.
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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