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P36 Unveils UDI Connect: Revolutionizing UDI Compliance in MedTech Sector

In a groundbreaking announcement, p36 GmbH, a prominent provider of digital compliance solutions in the life sciences sphere, has launched UDI Connect, a state-of-the-art software as a service (SaaS) solution tailored for medical device manufacturers. This innovative platform seeks to automate, integrate, and scale UDI compliance processes, addressing the needs of MedTech companies that have advanced internal governance practices yet are still reliant on manual submission methods.

Bridging the Compliance Gap

The introduction of UDI Connect aims to eliminate a long-standing bottleneck in medical technology compliance workflows. Despite significant investments in data validation and internal processes by many MedTech organizations, the final step of submitting data to regulatory databases such as EUDAMED and GUDID often remains a manual, prone to errors, and labor-intensive task.

According to Patrick Pfau, co-founder and CEO of p36, "The industry has seen widespread implementation of strong internal systems, yet manual submissions to regulatory authorities have continued to cause logjams and compliance risks. UDI Connect fills this gap by providing true automation, real-time validation, and seamless integration into existing IT landscapes, including SAP, PLM, and other systems that our clients have already established."

Key Features of UDI Connect

The UDI Connect platform boasts several critical functionalities designed to streamline compliance processes:

1. API-First Integration: The platform provides direct connections to existing systems such as SAP and custom databases, circumventing the need for disruptive system overhauls.
2. Automated Validation and Submission: Organizations can instantly validate and submit UDI data to multiple global authorities, significantly reducing both manual effort and the risk of human error.
3. Real-time Insights and Complete Traceability: Comprehensive dashboards and audit trails ensure transparency, assisting compliance teams and auditors alike.
4. Scalability for New Markets: UDI Connect empowers companies to expand their product portfolios globally and penetrate new markets like those in the EU and USA without altering existing workflows.

Supporting Compliance in a Dynamic Regulatory Landscape

With impending regulatory deadlines, such as the EUDAMED 2026 rollout, UDI Connect equips companies with the tools to shift from semi-automated to fully automated and end-to-end compliance processes. Whether preparing for regulatory audits or expanding into new territories, UDI Connect effectively bridges the gap between internal governance and global regulatory requirements.

A regulatory affairs manager at a leading MedTech firm that participated in the pilot program shared, "Our previous process was overly manual and complex, especially with the EUDAMED deadline approaching. With UDI Connect, we have streamlined compliance efforts and are excited about the prospect of easier market entry in the future."

About p36 GmbH

Since its inception in 2019, p36 GmbH has been a trusted partner for top-tier life sciences companies, offering customized cloud software solutions. As an independent, owner-operated technology enterprise, p36 specializes in consulting and development of SaaS solutions like UDI Connect, aiming to simplify regulatory processes, enhance digital transformation, and ensure compliance in an ever-evolving industry landscape. To learn more about p36 GmbH’s dedication to innovation, visit UDI Hub.

For further inquiries, contact:

• - Michael Teufel

Senior Marketing Manager
Email: [email protected]
Phone: +49 151 58879167