This seminar provides an easy-to-understand overview of how medical devices are regulated in Europe by the MDR. It will cover the most important requirements, relevant standards, guidelines, and best practices. You will be in a position to successfully navigate the approval process for your devices.
First, you will gain an overview of the European medical device regulatory framework. We will also show you the most important international standards and useful interpretation aids. You will then learn about a manufacturer's various roles and obligations and the steps required to obtain CE marking for your medical device in detail.
Finally, the topic has been clarified for me. I feel that I now better understand the definitions and connections within these topics.
I particularly liked the excellent structure, the division into two half-days, the practical exercises and the overall practical relevance, the excellent teaching methods, and the great learning materials.
You will derive the tasks from the MDR requirements in practical exercises. In doing so, you will create a roadmap that contains all the important steps on the way to CE marking. This roadmap will help you plan future market approvals for your medical devices step by step and implement the requirements thoroughly and efficiently.
The seminar offers participants the opportunity to share their experiences to date. We are also happy to discuss individual questions. Our experienced expert will be on hand to provide valuable tips from our daily practice.
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 know:
This seminar is designed for people who want to gain a detailed overview of the regulatory framework for medical devices in Europe and learn about the most important requirements for placing medical devices on the EU market.
Participants include:
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.
We use cookies on our websites. Some of them are essential, while others help us to improve this website and your experience.
