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In this seminar, you will learn about the individual components of technical documentation in accordance with the IVDR requirements and how to implement them with minimal effort and cost. That ensures nothing stands in the way of maintaining your devices' conformity or the successful market launch of new developments.
We provide you with an overview of the structural layout of technical documentation in accordance with Annexes II and III of the IVDR. You will gain detailed insights into the most important topics and learn how to implement the requirements. By the end, you will have a thorough understanding of the required content, its device-specific implementation, and the relationships between the various components.
The numerous exercises and examples were very beneficial, as were the group discussions, which helped to break up the dry subject matter.
Thanks to the practical teaching methods used in a series of exercises, you can start building your technical documentation in a targeted manner or review your existing documentation and revise it to comply with the IVDR. Among other things, you will learn how to formulate the intended purpose, apply the classification rules, analyze the state of the art, and prepare the summary report on safety and performance.
The seminar follows the concept of sustainable learning. It is characterized by alternating theory and practical exercises in several sprints, during which you can always exchange ideas with the lecturer and other participants as needed. In the sprints, you will develop a practical roadmap for technical documentation for IVD medical devices you can use in your company.
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
Contact Form
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. Understanding your own IVD 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.
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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