In this seminar on the EU Medical Device Regulation MDR (EU 2017/745), you will gain a compact overview of the most important requirements and learn how to implement them efficiently in your company within the applicable transition periods.
You will first learn how to categorize the MDR in regulatory terms before we go through the most important content step by step.
That mainly includes:
Very good contextualization of the content. Requirements were constantly classified. For example, mention of Z-systems, key points of different standards, classification in the context of the MDR, and relation to one's field of activity.
We show you how to implement the requirements in your company on time and without unnecessary effort. You will be able to revise your quality system, particularly your processes and specification documents so that you can continue to develop, market, and monitor your medical devices in compliance with the regulations.
This seminar has been offered since the MDR came into force. Since then, our team has accompanied countless companies on their way to successful MDR certification and is therefore well-informed about any amendments to regulations and published guidelines. Our expert will happily give you specific practical tips and answer your 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.
Phone
+49 7531 94500 20
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The seminar covers the following topics:
After the seminar, you will know:
This seminar is designed for individuals who want to gain a compact overview of the regulatory framework for medical devices in Europe and need proof of their professional qualifications.
Typical participants are:
Participants can easily follow this seminar even without any special prior knowledge. Understanding 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.
As a human biologist, Dr. Manuela Reinhold advises on regulatory issues and approval strategies for medical devices at the Johner Institute. She previously worked as a scientist, then in research and development, and served as a regulatory affairs manager at several medical device manufacturers. There, she prepared technical documentation, supported the conformity assessment of class I to III medical devices, and gained experience implementing regulatory requirements under MDD and MDR.
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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