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Ulrich Hafen is our specialist for regulatory requirements for medical laboratories. He assists manufacturers of in-house IVD medical devices in meeting IVDR requirements and provides support with strategic issues. He also helps with placing sampling sets on the market. He advises IVD users and manufacturers on setting up and maintaining QM systems in accordance with ISO 15189, Rili-BÄK Part A, and ISO 13485. Ulrich is also a certified QMR and supplier auditor and is the QMR of the Johner Institute.
After the seminar...
This seminar is designed for the following individuals: laboratory directors, physicians, and managers; equipment and process managers, service technicians, safety officers, field application and sales specialists from IVD and RUO manufacturers, as well as quality and RA managers in laboratories and clinics.
Participants can easily follow this seminar even without any prior knowledge.
After registering, you will receive a confirmation email containing the meeting link, the time, and information about the participants.
Within the next 48 hours, you will receive an invoice with a payment term of 14 days. If this payment term is not feasible for your company, please send a brief email to [email protected] to find a solution.
Three days before the seminar, you will receive two emails: The first contains the final link to the seminar, and the second includes access details to a cloud folder where you will find preparatory materials, exercises, and presentations.
Our online/remote seminars are conducted using the MS Teams video conferencing tool. We recommend that you log in 20 minutes before the seminar begins to resolve any technical issues in a timely manner. Our team is available at any time to assist with questions or problems.
At the end of the seminar, you will receive a feedback link for evaluation. We will send you your certificate of participation the following day.
If you encounter technical issues while participating or have any other questions, you can contact our support team at any time. The provided documents also include an emergency number to assist you in urgent cases.
Further technical and organizational questions are addressed in our general FAQ
Am Ende des Seminars findet eine freiwillige Online-Prüfung statt (Dauer: ca. 20 min). Mit Bestehen dieser Prüfung erhalten Sie zusätzlich zu Ihrer Teilnahmebescheinigung ein Zertifikat, das Ihre neu erworbenen Kenntnisse und Fähigkeiten nachweist.
Phone
+49 7531 94500 20
Contact Form
As a certified QMB and Lead Auditor, our instructor has not only supported numerous IVD users and manufacturers in establishing and maintaining their QM systems. He is also our specialist for regulatory requirements for medical laboratories and provides you with valuable advice and tips on how to navigate the interplay of legal requirements.
Compliant laboratory operations are based on structured and well-thought-out management that meets increasingly comprehensive regulatory requirements. This ranges from the qualification of equipment to the use of software solutions and the implementation of in-house developed systems (in-house IVD)
But how can these numerous requirements be met efficiently and in compliance with the law? What must be considered during hazard assessments and risk evaluations, and how can IT security requirements be successfully implemented? This is precisely where our seminar comes in, providing you with practical and easy-to-understand answers to these questions.
The requirements for modern medical laboratories go far beyond the well-known regulations of Rili-BÄK, the IVDR, and ISO 15189. Additional regulations such as the Medical Device Operator Ordinance (MPBetreibV), the Occupational Safety and Health Act (ArbSchG), and the Occupational Safety Act (ASiG) set strict standards for laboratory operations. Furthermore, the EU’s AI Act and the new data security requirements under NIS-2 introduce additional guidelines for the use of artificial intelligence and cybersecurity. Our seminar will show you how to implement all these requirements efficiently, in compliance with the law, and in a practical manner.
We haven't received any written feedback on this seminar yet. So let's let the recommendation rate speak for itself.
Alternatively, you can find reviews of other seminars taught by our instructor here.
From the Rili-BÄK to the AI Act: Modern laboratories face more far-reaching requirements than ever before.
Do you operate or manage a medical laboratory? Do you have a clear understanding of the multitude of national and European regulations and their implications for your daily work? This seminar provides a comprehensive overview of the key legal and regulatory requirements necessary for compliant and safe laboratory operations.
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