As a medical device manufacturer, you face a complex task: not only do you have to comply with ISO 13485 for quality management, but also with ISO 27001 for IT security, and now ISO 42001 for the use of AI.
The problem: Without the right strategy, redundant systems, contradictory processes, and unnecessary costs arise. The result is inefficient processes, higher audit costs, and, in the worst case, failure to obtain certification, which can delay or even prevent your market launch.
In this practice-oriented seminar, we show you how to seamlessly integrate ISO 42001 into your existing ISO 13485 and ISO 27001-compliant management systems.
You will first learn about the specific regulatory requirements for medical device manufacturers, identify synergies between the standards, and resolve potential conflicts. During the seminar, you will develop your individual project plan for the integrated management system. This project plan will be reviewed directly by the seminar instructors, allowing you to return home with a solid plan and begin implementation immediately – without losing time due to subsequent corrections.
We have not yet received any written feedback on this seminar.
Benefit from the experience of our experts, who have already successfully guided numerous companies through audits. In the seminar, you will receive concrete and proven practical tips that will maximize your chances of success in upcoming audits and certifications and help you avoid expensive follow-up audits.
At the end, you will know exactly what tasks await you and how you can use AI to accelerate the development of your integrated management system. With our master document and responsibility matrix, you will save weeks of preparatory work. You will know immediately which specification documents need to be adapted and which competencies need to be developed – without having to do any research or structuring yourself.
What makes this seminar special is that it is not a guided reading of the standard. You actively work on your individual solution and go home with a concrete, implementable plan. Instead of being overwhelmed with tasks, you receive a prioritized to-do list with the five most important next steps. The format, which is deliberately divided into two half-days, ensures that you remain focused and can optimally assimilate what you have learned.
During the seminar, discussions and exercises will be used to put what you have learned directly into practice. This serves as a test of effectiveness, and in addition to your certificate of participation, you will receive a certificate attesting to your newly acquired knowledge and capabilities.
Phone
+49 7531 94500 20
Contact Form
The seminar will cover the following topics:
After the seminar, you will:
This seminar is aimed at manufacturers of medical and in vitro diagnostic medical devices, in particular:
Typical seminar participants are:
Participants can easily follow this seminar even without any special prior knowledge. Understanding your own medical devices and QM system 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.
Medical IT engineer Claudia Schmitt supports Johner Institute customers in standards-compliant software development (IEC 62304), risk management (ISO 14971), and establishing management systems (ISO 13485, ISO 27001, ISO 42001). With nearly 20 years of experience in the development and approval of medical devices, as well as serving as a quality management representative, she understands the challenges and offers targeted support. Her knowledge and enthusiasm for ISO 9001, ISO 13485, ISO 27001, ISO 42001, IEC 62304, and ISO 14971 help companies to realize their visions.
After completing her studies, Claudia Volk gained several years of experience as a quality and regulatory affairs manager in a regulated environment, initially in food production and later as a management representative and PRRC for manufacturers of in vitro diagnostic medical devices. In this role, she established, developed, and audited QM systems and implemented digital QM tools. At the Johner Institute, she supports our customers in setting up and further developing their QM systems and in training their employees. She is also a certified lead auditor for various audit criteria, including MDR, IVDR, ISO 13485, ISO 9001, MDSAP, 21 CFR Part 820, and ISO 42001.
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.
We use cookies on our websites. Some of them are essential, while others help us to improve this website and your experience.
