This seminar gives you an overview of the requirements of the MDR, IEC 62304, and IEC 82304 for developing medical software (both medical device software and standalone software as a medical device). We show you how to optimally design and document your development process so that nothing impedes a successful audit.
Do you have any further questions? Would you like another appointment or consider an In-house seminar? Get in touch with us!
You will first learn about the legal requirements applicable in the EU and relevant standards and guidelines. Based on this, you will be able to determine whether your software is a medical device and what tasks and documents are required based on the corresponding risk class. Upon request, we can also explain the differences regarding the FDA's requirements so that you can take these into account.
I really liked the methodology, seminar structure, course content, integration of theory and practice, very good practical examples, clear and competent explanation of complex topics, and finally, very good interactive communication between the trainer and participants.
You will learn how to optimally design or improve your software development process using suitable case studies and exercises. Among other things, we will show you how to reconcile agile development practices with other regulatory processes. You will also gain an understanding of how comprehensive and detailed the documents in the software file should be.
Our expert has almost 20 years of experience in medical informatics and quality management. She has primarily been responsible for the required software files and is, therefore, very familiar with the various perspectives on the development and approval process. She can provide useful tips, best practices, and rules of thumb to help you pass your audit safely and without unnecessary effort.
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:
This seminar is designed for people who:
Participants can easily follow this seminar, even without any special prior knowledge.
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.
Medical IT engineer Claudia Schmitt supports Johner Institute customers in standards-compliant software development (IEC 62304), risk management (ISO 14971), and the establishment of management systems (ISO 13485, ISO 27001). With almost twenty years of experience in developing and approving medical devices and as a quality management representative, she understands the challenges and offers targeted support. Her knowledge and enthusiasm for regulatory affairs help companies to realize their visions.
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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