In this seminar, you will learn about the FDA's 510(k) procedure and, using concrete examples and exercises, how to deal with the relevant laws, guidance documents, and electronic eSTAR templates.
You will first learn about the 510(k) procedure and the submission requirements, with a particular focus on documentation. We will then show you how to select a suitable predicate device and prepare the substantial equivalence discussion. We will also discuss relevant guidance documents and how to deal with special controls and recognized standards.
We have not yet received any written feedback on this seminar.
You will learn from concrete examples how to determine the correct 510(k) type and submit pre-subs, for instance. In addition, we will work with you to create the documentation in eSTAR format and familiarize you with the FDA template. By dividing the seminar into two half-days with a week in between, you can start the actual implementation and clarify any questions that arise directly with our expert.
We don't just teach you theory; we also provide you with important practical tips and experience. Our lecturer regularly carries out 510(k) submissions for various manufacturers and can therefore give you valuable first-hand tips and feedback on what the FDA looks for during its reviews, the level of detail expected, and the formalities you need to take into account.
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:
After the seminar, you will be able to:
This seminar is designed for:
Basic knowledge of the FDA's general requirements is recommended, e.g., through our "FDA Compact Seminar," but is not mandatory.
Basic English skills are required to read and understand English texts.
To edit the FDA's eSTAR template, you will need a PDF editing program, such as Adobe Professional or PDF-XChange Editor.
Participants who have a specific device in mind for which the 510(k) submission is to be submitted will benefit most. Alternatively, a sample device provided can be used.
Important: If you wish to submit an IVD medical device, please send us a brief note when registering for the seminar so we can prepare the correct templates.
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.
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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