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The p36 story began in Bad Hersfeld, Germany, when founders Patrick and Robin recognized a critical need in the life sciences industry: mastering regulatory complexity through technology. Drawing on their deep SAP experience and exceptional regulatory know-how, Patrick and Robin set out to build solutions that not only address today’s compliance challenges but are also ready for tomorrow’s demands. The result: the p36 UDI Platform.With decades of combined SAP expertise, Patrick and Robin led p36 to develop cloud-based software that integrates natively with SAP Business Technology Platform (BTP). Their vision to empower medical device manufacturers to manage compliance processes, product master data, and regulatory submissions with confidence and agility became true. This customer story shows how a leading medical device manufacturer partnered with p36 to manage global UDI compliance and drive efficiency.

• Active market monitoring: Continuous updates on global UDI regulations keep compliance strategies current.
  
• Automated workflows: Streamlined data validation and submission processes reduce manual effort and errors.
  
• Centralized data governance: End-to-end management of UDI-related product master data, supporting both SAP and non-SAP environments.
  
• Enterprise integration: Ready for SAP S/4HANA and SAP BTP, but flexible for other IT landscapes.
  
• Scalability and future-readiness: Easily adapts to new regulatory demands and organizational growth.
  
• Ongoing innovation: The platform is continuously enhanced, with new features and capabilities developed in direct response to market demands and evolving regulatory requirements.
  

With p36’s UDI Platform, the manufacturer achieved:

• Time-to-market for UDI reporting reduced from 45 days to just 4 days.
  
• Improved data quality through automated checks and a single source of truth.
  
• Audit readiness with comprehensive tracking and reporting.
  
• Enterprise integration: Ready for SAP S/4HANA and SAP BTP, but flexible for other IT landscapes.
  
• Lower compliance costs and risks, enabling focus on innovation and expansion.
  

“p36’s UDI Platform has transformed our compliance processes. We’re now able to launch products globally with confidence, knowing our UDI submissions meet every market’s standards. The partnership is a cornerstone of our regulatory strategy.”
— Regulatory Affairs Manager

By partnering with p36, the manufacturer is equipped for future regulatory changes, new product launches, and global market expansion. The platform’s SAP-native architecture and proactive market monitoring keep them ahead, no matter how compliance evolves. As market needs shift, p36 remains committed to the ongoing development of the UDI Platform, ensuring it always meets the latest industry and regulatory demands.

With every new challenge and every conversation with our customers, we evolve our solutions and deepen our expertise to ensure that UDI compliance becomes simpler, smarter, and truly future-ready. The UDI Platform continues to evolve: new features and functions are regularly developed, and the technology has expanded to run on AWS for even greater scalability and flexibility. With new regulations, shifting market requirements, and evolving authority guidelines like we see in Europe (EUDAMED and the MDR), we maintain a close ear to the market. By continuously listening to MedTech and Life Science companies worldwide, our expertise has grown and led to the development of new solutions that put UDI compliance on autopilot: UDI Connect and UDI Hub.

UDI Connect is the latest addition to our product portfolio: an API-driven solution designed to integrate directly with the existing IT environment and help teams navigate complexity, stay compliant, and remain focused on innovation.

UDI Hub will be launched in Fall 2025. The solution will automate compliance tasks and provide intuitive tools for data preparation, submission, and tracking.
Excel spreadsheets can be used to import existing data, and in-app single and bulk operations allow to add missing data. Data validation mechanisms support in filling in the right data before sending it to EUDAMED.

As the regulatory landscape continues to evolve, so does we: driven by innovation, customer feedback, and a commitment to excellence. By partnering with MedTech and Life Science companies worldwide, we ensure solutions remain at the forefront of compliance and technology.The journey to reliable UDI compliance continues with us - p36.