In this seminar, you will explore the fundamental aspects of biocompatibility, including the regulatory requirements surrounding the ISO 10993 family of standards and laboratory testing.
Through practical examples and exercises, you will get the tools you need to test the biological safety of your medical device and document it compliantly.
Our experts will teach you the basics of biocompatibility using various illustrations and examples.
You will then understand:
Finally, I have been able to put this topic into context. I feel that I now better understand the definitions and interrelationships involved.
Through practical exercises, you will learn how to demonstrate your device's biological safety in the technical documentation. We will show you how the plan and report can be structured and which content and references are essential. You will also receive useful tips and specific structural suggestions so that biological safety will no longer be a headache in audits.
We developed the seminar at the request of our customers, who wanted further training in the ISO 10993 family and the biocompatibility of medical devices. Our lecturers have hands-on experience from several years of laboratory work and have already supported hundreds of companies in demonstrating biological safety.
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:
This seminar is designed for people who work closely with biocompatibility experts.
These include, for example:
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.
Dr. Tanja Domke supports our customers as a consultant on all aspects of clinical evaluation and in vitro biocompatibility. After completing her doctorate in stem cell biology at the University of Dundee, she spent several years working in clinical management. Dr. Domke then worked in the field of benefit assessment and market access for pharmaceuticals, both as a service provider and in the management of a global pharmaceutical company. She has supported Johner Institute customers with her cross-disciplinary expertise and scientific background since 2023.
Sarah Gruber is a biotechnology engineer who has been working in product safety for many years, with core competencies in biocompatibility and toxicology and final cleaning, sterilization, and reprocessing of reusable medical devices. As an expert in the biological safety of medical devices, she supports our customers with her experience in the strategic planning of the necessary tests, the organization and supervision of laboratory tests, and the risk-based toxicological evaluation of the results from development to the approval of the medical devices.
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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