In this seminar, you will learn how to plan the individual performance evaluation of your IVD medical device in a targeted manner and implement the requirements of the IVDR in a device-specific way. It will give you everything you need to demonstrate the performance of your IVD medical device on your own and in compliance with regulations.
Do you have any further questions? Would you like another appointment or consider an In-house seminar? Get in touch with us!
You will first learn about the regulatory requirements of the IVDR and valuable guidance documents. That will give you an overview of which actiities you need to implement during the performance evaluation process of your IVD medical device and when and how to document them in a corresponding performance evaluation file.
I highly recommend this seminar. It is perfect for beginners and experienced professionals working in the field of in vitro diagnostics. It provides a good and informative introduction to the topic with in-depth insights and exercises, e.g., in terminology, data analysis, and literature research. I came out of this seminar with significantly more knowledge than I went in with. Thank you!
You will consolidate what you have learned in the seminar through various exercises. These will enable you to derive and justify a device-specific performance evaluation strategy, plan the necessary resources in a targeted manner, and develop a performance evaluation plan.
As further support, we provide various accompanying documents: a formulation template for a precise intended purpose and an IVDR-compliant template for your performance evaluation plan. Our experienced expert will also be on hand during the seminar to provide numerous tips on device-specific implementation.
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:
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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