This seminar provides the perfect foundation for understanding the IVDR requirements for in-house IVD medical devices (IH-IVD), often called laboratory developed tests (LDT), and determining what needs to be done and in what order. You will then have the knowledge you need to continue using your IH-IVD in compliance with the law.
You will first learn the definition of IH-IVD medical devices and all relevant regulatory requirements that apply to you as a medical laboratory. We will focus, in particular, on the priority with which these must be implemented so that you can organize your schedule perfectly.
I particularly liked the high level of information, the presentation style, and the practical relevance. Questions were welcome anytime, and specific questions and situations relating to individual seminar participants were addressed.
The seminar is characterized by a high degree of interaction, discussion, and exchange. It is particularly important to us to provide the content in a practical manner. In addition to the seminar documents, you will receive further helpful templates and mind maps that you can use to get started immediately in your organization.
Our lecturer will encourage you to think outside the box and discuss the interaction between the IVDR and other regulations. We will compare the requirements of the IVDR and MDCG 2023-1 with those of ISO 15189, ISO 22367, Rili-BÄK, and regulations such as MPBetreibV and MPAMIV.
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:
This seminar is designed for:
No special requirements are necessary. However, participants should have a basic understanding of laboratory processes, regulations, and quality management.
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.
Ulrich Hafen is our specialist for regulatory requirements for medical laboratories. He assists manufacturers of in-house IVD medical devices in meeting IVDR requirements and provides support with strategic issues. He also helps with placing sampling sets on the market. He advises IVD users and manufacturers on setting up and maintaining QM systems in accordance with ISO 15189, Rili-BÄK Part A, and ISO 13485. Ulrich is also a certified QMR and supplier auditor and is the QMR of the Johner Institute.
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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