This seminar will help you to understand the FDA's new requirements for your quality management system (QMS). You will learn what changes there are with regard to harmonization with ISO 13485:2016 and how to implement them in your company successfully.
Do you have any further questions? Would you like another appointment or consider an In-house seminar? Get in touch with us!
You will learn about the requirements of the new Quality Management System Regulation (QMSR) in detail.
We will show you:
Since ISO 13485 is a large part of the QMSR's content, the seminar will discuss and analyze all ISO 13485 requirements. We will also highlight additional FDA requirements.
The seminar is, therefore, aimed at people who have little or no knowledge of ISO 13485 or who want to improve and deepen their existing knowledge.
Extremely competent and likeable expert. The seminar is well organized, good amount of content and flow of the training. The discussions on how processes can be carried out were very good.
The seminar does not consist of purely frontal teaching sessions but lives from interaction and working through the requirements from the original text. Our experts will show you how to correctly interpret the regulatory and normative requirements and derive the necessary tasks from them.
Our trainers have many years of experience and in-depth knowledge in the implementation, optimization, and auditing of various QM systems and can give you valuable tips on how to cleverly combine all the requirements relevant to you and implement them in a lean and even beneficial way.
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+49 7531 94500 20
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The seminar covers the following topics:
After the seminar, you will know:
This seminar is designed for people who have/will take on one or more of the following roles:
The seminar is aimed at people with little or no knowledge of ISO 13485. Therefore, participants can easily follow this seminar without any special previous 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.
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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