This seminar helps you understand the principles and requirements of the medical device single audit program (MDSAP) and derive the necessary preparatory measures for your company.
First, we would like to help you develop an understanding of all aspects of the audit programme. You will learn how the MDSAP came about, which countries participate, and how the basic concept works. We will also address country-specific requirements.
I particularly liked the systematic structure. In my opinion, the most important topics were discussed, including how to approach a gap analysis practically and start an MDSAP project.
In the seminar, our lecturers will explain how an MDSAP audit works, what rules apply to classifying deviations, and what consequences these deviations entail. Using a concrete example, we will also illustrate the evaluation of deviations and their efficient remedy.
Our experts have many years of practical experience with MDSAP audits and are happy to share this with you. Using the requirements catalogue of the certifying organizations, they will show you how to best prepare for the audit programme and give you valuable tips on what to look out for.
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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+49 7531 94500 20
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The seminar covers the following topics:
After the seminar, you will be able to:
This seminar is designed for:
You should know about ISO 13485. An understanding of the process of internal or external quality management audits is a plus.
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 completing her studies, Katrin Schnetter gained extensive experience as a quality management representative and regulatory affairs manager in the IVD medical device and medical device environment at international corporations. She has established and further developed both quality management systems and ISM systems. A global and networked approach is important to her. At the Johner Institute, she supports our customers in setting up, implementing, and further developing QM and ISM systems, focusing on integrated management systems. She also works as an internal auditor.
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.
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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