p36 GmbH Launches UDI Connect for Automated Compliance in MedTech

Sep 16, 2025
p36 GmbH has introduced UDI Connect, a SaaS solution aimed at automating compliance processes for medical device companies, as announced in a press release.

p36 GmbH has launched UDI Connect, a next-generation SaaS solution designed to automate compliance processes for medical device companies. Announced in a press release, UDI Connect addresses the persistent challenge of manual data submissions to regulatory databases like EUDAMED and GUDID, which are often error-prone and labor-intensive.

The solution offers real-time validation and seamless integration with existing IT systems, including SAP and PLM, without requiring any system replacements. Key features include API-driven integration, automated data validation and submission, and comprehensive dashboards for real-time insights and audit trails. This enables companies to expand their product portfolios globally and enter new markets such as the EU and the US without altering existing workflows.

As regulatory deadlines like EUDAMED 2026 approach, UDI Connect provides a fully automated compliance process, bridging the gap between internal governance and global regulatory requirements.

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