In this seminar, you will learn about the tasks and duties of the Person Responsible for Regulatory Compliance (PRRC) required by the MDR and IVDR and how to perform your new role in the company in accordance with the requirements.
First, you will gain insight into the legal basics and learn how to correctly interpret the regulatory requirements and relevant guidance documents. Based on this, we will show you what taking on this role will mean for you in concrete terms.
The trainer explained in a very pleasant, expert and, above all, understandable manner what the role of PRRC entails. It was also impressive that, based on his extensive practical experience, he could provide examples of the daily practice in the role mentioned.
In the seminar, we focus on implementation in the company.
You will learn:
Our expert will provide you with valuable tips and assistance for delegating responsibility and dealing with disputes. He will also present you proven solutions using the example of the comparable Qualified Person from the pharmaceutical sector.
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 know:
This seminar is designed for individuals who, for example, perform one or more of the following roles:
Knowledge of the regulatory requirements of the MDR and IVDR is helpful. However, participants can follow this seminar well even without detailed prior knowledge, as a brief introduction to the regulatory basics is part of the seminar. An understanding of your own medical devices is also 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.
Dr. Bernhard Gerstenecker has a PhD in microbiology and has spent his entire professional life in the medical device industry dealing with all aspects of IVD systems. For around 25 years, he developed immunochemical reagents and test procedures, established and further developed QM systems, and worked on regulatory affairs requirements. In addition, he worked for ten years in the IVD medical device industry as a quality and regulatory affairs manager. At the Johner Institute, he supports our customers in outsourcing regulatory roles such as external QMR and PRRC, establishing eQMS solutions, reviewing technical documentation, and conducting 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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