Your To Dos by 28 May 2026
Webcode 26042503
Pascal Appel
p36 GmbH, Bad Hersfeld
UDI Content Engineer; Pascal Appel is a UDI Content Engineer with extensive experience in the technical implementation of regulatory requirements for medical device manufacturers. His focus is on the UDI/Device and Actor modules within EUDAMED. Additionally, he has in-depth knowledge of international UDI databases such as GUDID (USA) as well as systems from South Korea, China, Saudi Arabia, Taiwan, and Australia. He specializes in the development, validation, and optimization of data models and interfaces in the context of software development for the p36 UDI Platform.
Przemyslaw Kowalski
p36 GmbH, Bad Hersfeld, GERMANY
UDI Subject Matter Expert; Przemyslaw Kowalski is a UDI Subject Matter Expert at p36 GmbH, where he authors and leads specifications for new UDI market extensions, bridging RA and IT execution. With a pharmacy degree and broad experience in Regulatory Affairs and Quality Management, he turns complex requirements into pragmatic, scalable outcomes. He has led multiple UDI software implementations for major MedTech companies worldwide and collaborates with national regulatory agencies on the rollout of their UDI databases-including EU EUDAMED, US GUDID, and Australia's AusUDID.
15/04/2026
15/04/2026
from 09:00 to 17:00
online
online
Event - 1,290€ plus tax
The registration fee includes downloadable documentation, a certificate, access to the Learning Space, and technical support including the PreMeeting.
Event - 1,290€ plus tax
The registration fee includes downloadable documentation, a certificate, access to the Learning Space, and technical support including the PreMeeting.
Verena Planitz
Conference Manager
+49 6221 500-655
v.planitz@forum-institut.de
Be fully prepared for the mandatory EUDAMED go-live from 28 May 2026. The seminar provides a practical overview of key regulatory requirements and how to translate them into an actionable plan across Regulatory, Quality and IT. The focus is on SRN readiness, UDI master data design, data quality for large portfolios and reliable procedures for registrations, updates and certificate data.
Be fully prepared for the mandatory use of the first four EUDAMED modules from 28 May 2026: Actor Registration (SRN), UDI/Devices, Notified Bodies and Certificates, and Market Surveillance. This seminar will help you translate the regulatory requirements into a clear and structured action plan across Regulatory, Quality and IT. This includes SRN readiness, the design of UDI master data (Basic UDI DI, UDI DI, EMDN), data quality considerations for large portfolios and the establishment of reliable procedures for registrations, updates, versioning, inactivation, and linkages to certificates and vigilance records.
Welcome and objectives
Przemyslaw Kowalski
Przemyslaw Kowalski
Coffee break
Przemyslaw Kowalski
Przemyslaw Kowalski
Przemyslaw Kowalski
Lunch
Pascal Appel
Pascal Appel
Coffee break
Pascal Appel
Pascal Appel
Pascal Appel
Pascal Appel
End of Seminar
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The pre-meeting gives you the opportunity to explore our Learning Space and to familiarise yourself with the technology to start off your online training on the right foot. This is a non-binding offer for all our customers and not a prerequisite for participation. If a pre-meeting date does not suit you but you would still like a technology check, please contact us.
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