This seminar will help you navigate the regulatory jungle and label and register your medical devices in accordance with the MDR.
You will first learn about the general requirements for UDIs to understand how UDIs are assigned and allocated in practice. After the seminar, you will know exactly which packaging levels of your devices you need to label and how and when you need to assign new UDIs.
The topics were well structured, and there were exercises in between. That really helped to consolidate what we had learned. The instructor was very knowledgeable and had an answer to every question, which was easy to understand.
Our expert will provide all the information you need to register economic operators and devices in EUDAMED. She will pay particular attention to the respective transition periods for registering and labeling your medical devices.
To consolidate what you have learned immediately, several practice blocks are integrated into the seminar. In these, you work with other participants to develop solutions to various problems. Of course, there will also be plenty of time for discussion and your individual questions.
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:
You will know:
This seminar is designed for individuals who:
Participants should be familiar with the general requirements and structure of the MDR and IVDR. We also recommend our Compact Seminar Medical Device Regulation (MDR).
No special prior knowledge of UDI is required. An understanding of your own 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.
After studying biomedical engineering and completing further training as a regulatory affairs manager, Katharina Keutgen spent many years working in development and regulatory affairs for manufacturers of heart-lung machines and vascular access devices. There, she acquired comprehensive regulatory expertise. As a member of the medical device team, she has been supporting Johner Institute customers since 2021 with international approvals and questions relating to the regulatory strategy for medical devices. She conducts seminars and workshops on FDA requirements and UDI.
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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