p36 Unveils UDI Connect: The Future of Automated UDI Compliance for MedTech

p36 GmbH, a leading provider in digital compliance solutions tailored for the life sciences industry, recently announced the official launch of UDI Connect. This next-generation SaaS solution is specifically designed for medical device companies that have already established robust internal UDI governance and are now eager to automate their compliance processes for global markets.

The significance of UDI Connect lies in its ability to address a long-standing gap in UDI processes. Within the medtech sector, many companies have invested heavily in data validation and internal workflows. However, the final step—submitting UDI data to regulatory databases like EUDAMED and GUDID—has often remained a manual, labor-intensive, and error-prone task. Patrick Pfau, co-founder and CEO of p36, shared insight into the industry’s struggle: "While it was common to see solid internal systems implemented, manual submissions to regulatory authorities continued to create bottlenecks and non-compliance risks. UDI Connect solves this challenge by providing true automation, real-time validation, and seamless integration into existing IT landscapes such as SAP, PLM, and other systems our clients utilize."

Key Features of UDI Connect

1. API-Focused Integration: The solution connects directly to existing systems such as SAP and custom databases, eliminating the need for extensive modifications or replacements.
2. Automated Validation and Submission: Instantly checks and submits UDI data to various global authorities, significantly reducing manual workload and mitigating human error.
3. Real-Time Insights and Comprehensive Verifiability: Offers complete transparency through extensive dashboards and audit trails, aiding compliance teams and auditors alike.
4. Scalability for New Markets: Empowers companies to expand their product portfolios globally and enter new markets such as the European Union and the United States without disrupting their existing workflows.

As regulatory deadlines loom, such as the EUDAMED deadline in 2026, UDI Connect is positioned to help businesses transition from semi-automated compliance processes to fully automated end-to-end solutions. This robust tool is not only designed to facilitate growth into new markets but also prepares firms for upcoming regulatory inspections. A regulatory affairs manager from a prominent medical technology company participating in the pilot program commented, "Our previous process was overly manual and complex, especially as we approached the EUDAMED deadline. With UDI Connect, we have simplified our compliance process and look forward to easily adding new markets in the future."

About p36 GmbH

Established in 2019, p36 GmbH is dedicated to empowering leaders in the life sciences sector worldwide by providing cutting-edge cloud-based software. As an independently managed technology firm, our specialty lies in consulting and developing SaaS solutions like UDI Connect that simplify regulatory processes, drive digital transformation, and help organizations maintain compliance in an ever-evolving industry landscape. Explore our commitment to innovation at udihub.io. For further information, please contact:

Michael Teufel
Marketing Manager
p36 GmbH
Email: [email protected]
Phone: +49 151 58879167