In this seminar, you will learn about the basic regulatory requirements imposed by the FDA on the marketing of medical devices in the US. You will learn how to classify your medical device correctly, determine the appropriate market access procedure, which documents are required, and how you can help yourself in case of doubt.
You will first learn about the relevant laws, guidance documents, and recognized standards. Our experts will show you which procedures for market entry are available in the US and which requirements you must implement. You will then be able to estimate the associated efforts accurately.
I particularly liked the opportunity to run through the case studies using our own devices and ask specific questions.
We show you how to classify your medical devices correctly, select the suitable market entry procedure, and identify the documentation required in each case. You will also learn how best to contact the FDA and in which cases it is worthwhile.
During the seminar, you will develop a regulatory strategy concept using your own device or an example device. You can then use this as a basis for future medical devices. Our experienced experts will be on hand to answer specific questions and provide valuable practical tips.
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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The seminar covers the following topics:
In this seminar, you will learn about the basic requirements that the FDA imposes on the marketing of medical devices, which you and your company must know, understand, and fulfill.
After the seminar you will be able to:
This seminar is aimed at individuals involved in marketing medical devices in the US who would like to gain an overview of the FDA requirements. It is also aimed at individuals entering the US market for the first time with little or no experience.
This applies in particular to:
The seminar is also suitable for beginners and those who "only" want to gain an overview of the US FDA requirements. However, depending on the participants' expectations, the lecturers will also address specific questions in detail.
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.
Margret Seidenfaden studied medical technology and business administration and has several years of experience in international medical device approval. After working for medical device manufacturers in regulatory affairs, she now supports customers at the Johner Institute with questions and challenges relating to international requirements for medical devices and their approval. As a lecturer, her objective is to present the requirements clearly and understandably and identify commonalities and recurring tasks, thereby making the regulatory effort more predictable.
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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