This seminar will optimally prepare you to meet the regulatory requirements for your medical software. Practical exercises and valuable tips will help you quickly and easily implement your new knowledge in your company.
Do you have any further questions? Would you like another appointment or consider an In-house seminar? Get in touch with us!
The seminar covers the relevant legal requirements and standards for medical software. Our top experts, who have not only helped countless software manufacturers meet the requirements but are also experienced auditors, will provide you with this expertise directly.
Very practical and packed with tips from personal experience, relaxed and friendly interaction with participants, the trainers responded to questions in a precise manner, excellent exam preparation and clear explanations, as well as many practical examples and tips.
Using various case studies and tasks, you will practice what you have learned directly in the seminar. You will also benefit from valuable tips on transferring what you have learned to your company in a targeted manner and according to the state of the art.
Upon passing the final exam, you will receive a certificate attesting to your newly acquired knowledge and capabilities. The exam is online and conducted by an independent, accredited examination organization. You will have one hour to answer 32 multiple-choice questions. The exam fee is charged in addition to the seminar price.
At the end of the seminar, an online exam will be conducted by an independent examination organization (duration: 60 minutes). You will receive the “Certified Professional for Medical Software” certificate upon passing this exam.
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+49 7531 94500 20
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The seminar covers the following topics:
After the seminar, you will be prepared to pass the Certified Professional for Medical Software exam. You can find the detailed curriculum here:
https://icpmsb.de/wp-content/uploads/2024/03/Curriculum_V3en.pdf
This seminar is designed for anyone who works with medical software in their everyday professional life, e.g.:
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, daily from 9:00 am to 5:00 pm during the specified period. There will be a one-hour lunch break every day and short breaks as needed. The exam takes place on the last day of the seminar at approximately 3:30 pm.
The duration of the individual learning units depends on the participants' knowledge level and the number of questions that arise. Therefore, no exact times can be provided.
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.
Sven Wittorf has been part of the Johner Institute since 2006, starting as a consultant for software development processes. He is passionate about how regulatory requirements can be mapped into coherent data concepts to make processes more efficient for manufacturers and notified bodies on the one hand and to improve the quality of documentation and, thus also, of devices on the other. In 2012, he founded the sister company Medsoto together with Christian Johner, which supports manufacturers in implementing ALM tools.
Matthias Hölzer-Klüpfel studied physics at the University of Würzburg. He has been a developer, consultant, and project manager since 2002 and has carried out numerous medical technology projects for both SMEs and large companies. In addition to his professional activities, he completed a master's degree in IT in Healthcare in July 2009. He is co-founder of the association "ICPMSB e.V.," which develops the basis for certification as a "Certified Professional for Medical Software," and co-author of the textbook "Basiswissen Medizinische Software" (Basic Knowledge of Medical Software). He also heads the "Software in Medical Technology" technical committee at the Association of German Engineers (VDI). He works as a freelance consultant on all issues relating to development processes for medical devices and supports numerous companies in software development.
Urs Müller works as a consultant at the Swiss Johner office and supports customers and projects in product development and the development of production equipment for medical technology, focusing on verification, validation (CSV), and software development. Since completing his computer science degree, Urs has worked in the software development service sector, first as a test automation engineer/tester and later as a team leader in an engineering company focusing on medical device development. Quality-driven development is in Urs' blood, and he enjoys sharing his enthusiasm for it with colleagues and customers.
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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