#Germany #MedTech #UDI Connect #p36 GmbH #Bad Hersfeld

p36 GmbH Launches UDI Connect for MedTech Compliance

Bad Hersfeld, Germany – September 15, 2025
In a move poised to revolutionize the medical technology sector, p36 GmbH, a pioneer in digital compliance for life sciences, has recently launched UDI Connect. This next-generation Software as a Service (SaaS) solution is meticulously designed for medical device companies that have already established a solid foundation in Unique Device Identification (UDI) governance and are looking to automate and expand their compliance efforts globally.

Bridging the Compliance Gap

Despite substantial investments in data validation and internal processes, many MedTech organizations still find themselves grappling with the manual, error-prone, and labor-intensive process of submitting data to regulatory databases such as EUDAMED and GUDID. Patrick Pfau, the Co-Founder and Managing Director of p36 GmbH, emphasizes the challenges faced by companies: "While strong internal systems are standard, the manual submission process to regulatory authorities continues to create bottlenecks and compliance risks. UDI Connect is designed to bridge that gap, providing true automation and real-time validation."

Key Features of UDI Connect

• - API-First Integration: UDI Connect boasts seamless connectivity to existing systems, including SAP and custom databases, allowing for a straightforward integration without the need for a complete overhaul.
• - Automated Validation Submission: The solution instantly checks and submits UDI data to multiple global authorities, significantly reducing the manual workload and the potential for human error.
• - Real-Time Insights & Auditability: Comprehensive dashboards and audit trails provide full transparency to compliance teams and auditors.
• - Scalability for New Markets: Organizations can expand their product portfolios internationally, entering new markets like the EU and US without the need to alter established internal workflows.

Meeting Regulatory Demands

As regulatory deadlines approach, notably with the EUDAMED 2026 coming up, UDI Connect equips organizations to transition from semi-automated to fully automated, end-to-end compliance processes. This is critical not only for expanding into new markets but also for preparing for regulatory inspections. A Regulatory Affairs Manager from a leading MedTech company that participated in UDI Connect's pilot program highlighted the efficiency gained: "Our previous processes were overly manual and complicated, especially with the upcoming EUDAMED deadline. UDI Connect not only streamlined our compliance but also positioned us to expand into new markets more effortlessly."

About p36 GmbH

Since its inception in 2019, p36 GmbH has been dedicated to empowering top-tier life sciences companies worldwide with tailored cloud solutions. With expertise in developing SaaS tools like UDI Connect, p36 GmbH remains committed to simplifying regulatory processes and enabling businesses to navigate the complexities of an ever-evolving industry landscape. For additional information about their innovative tools and services, visit their website at p36 GmbH.

Conclusion

The launch of UDI Connect by p36 GmbH highlights a critical innovation in the MedTech landscape, addressing long-standing challenges with automated solutions that enhance efficiency and compliance. As the industry continues to evolve, UDI Connect promises to be a vital resource for businesses aiming to succeed in an increasingly complex regulatory environment.