In this seminar, you will learn what ISO 13485:2021 requires and how your company can confidently pass audits while reducing QM bureaucracy.
The seminar combines theory with practical exercises, offering valuable insights and best practices to provide concrete guidelines for action.
Do you have any further questions? Would you like another appointment or consider an In-house seminar? Get in touch with us!
You will gain an overview of the requirements of ISO 13485 and will be able to create lean and pragmatic standard operating procedures. It will enable you to prepare for and accompany internal and external audits confidently. You will also learn how to meet quality management requirements outside the EU.
I found the training well structured and informative. I particularly liked the fact that you took a short break every hour, which refreshed my ability to absorb information. I also appreciated that the trainers answered many questions and always clearly answered them. I also liked that they often referred directly to the standard's wording, leaving no room for subjective interpretation.
Unlike a purely theoretical lecture, our instructors help you transfer what you have learned directly into your everyday work with practical exercises and sample documents. Instead of clinging to rigid plans and examples of little relevance to practice, they explain the material using current and real devices and address your specific case.
Unlike other auditors, our trainers don't just point out mistakes. They draw on their daily work experience to share best practices that help others quickly create accurate and compliant QM systems, enabling them to pass audits and reviews confidently. This seminar provides you with concrete guidance and precise answers to your questions.
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+49 7531 94500 20
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The following topics are covered in the seminar:
Basics
ISO 13485 at a glance
Sections 1-3 of ISO 13485
Sections 4-8 of ISO 13485
Consolidated requirements and interpretation of the standard
Implementation and further topics
After the seminar, you will be able to:
This seminar is designed for career starters and career changers who (in the future) will take on one or more of the following roles:
The seminar is aimed explicitly at young professionals and career changers. Participants can, therefore, follow this seminar easily, even without any special prior knowledge. A basic understanding of your own company and its processes is helpful but not a prerequisite.
You will need the ISO 13485 standard to participate fully in the seminar.
Please get in touch with us if we can assist you with this or provide you with tips.
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.
After studying health management, Dirk Bethäußer worked for many years at various medical device manufacturers, where he was responsible for setting up and expanding an entire QM department as Director of Regulatory Affairs and QM. His job included conformity assessment procedures, risk management, technical documentation management, employee training, and auditing. As a sought-after expert and lecturer, he supports our customers in setting up, implementing, and maintaining their QM systems and training their employees. He also ensures success in ISO 13485 certification through countless internal audits.
Andreas Kalchschmid-Lehmann is an expert in QM and in vitro diagnostic medical devices with more than 17 years of practical experience. He is the author of the book “ISO 13485 – Chance statt Hürde” (ISO 13485 – Opportunity instead of obstacle) and has relevant experience in other quality management systems, including ISO 17025, ISO 15189, MDSAP, and CFR 820. As a former quality manager, he knows how to set up and implement a QMS successfully. He worked as a product specialist and lead auditor at a large notified body. Today, as a widely recognized expert, he supports our customers and trains auditors for notified bodies as a lecturer in a certified course at the Johner Institute.
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 training their employees.
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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