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

p36 GmbH Unveils UDI Connect

p36 GmbH, a prominent name in providing digital compliance solutions within the life sciences domain, has officially introduced UDI Connect, a revolutionary Software as a Service (SaaS) platform. This innovative solution caters specifically to medical device companies that have progressed beyond the limitations of manual compliance submissions.

Addressing Compliance Challenges

For many stakeholders in the MedTech industry, managing Unique Device Identification (UDI) compliance has been a significant challenge. Despite substantial investments in robust data validation and internal workflows, the crucial phase of submitting data to regulatory agencies often remains cumbersome, manual, and prone to errors. As Patrick Pfau, Co-Founder and Managing Director of p36, states, “While strong internal systems are common throughout the industry, the bottlenecks created by manual submissions have led to compliance risks.” UDI Connect aims to bridge this gap, enhancing automation and streamlining the submission process.

Key Features of UDI Connect

UDI Connect shines with several noteworthy features that set it apart from traditional compliance solutions:

1. API-First Integration: The platform seamlessly integrates with existing systems, including SAP and custom databases, alleviating the need for a complete system overhaul.
2. Automated Validation: Submissions are instantly checked and sent to multiple global regulatory authorities, significantly minimizing manual efforts and reducing human error traces.
3. Real-Time Insights and Auditability: Comprehensive dashboards provide transparency, supporting both compliance teams and auditors alike, ensuring thorough traceability.
4. Scalability for New Markets: Organizations can expand their product portfolios and penetrate new markets like the EU and the US without overhauling their internal workflows.

The Future of Compliance in MedTech

With impending regulatory deadlines such as EUDAMED 2026, UDI Connect empowers companies to transition from semi-automated to fully automated compliance processes. As one Regulatory Affairs Manager from a leading MedTech company shared, “The old process was overly manual and complex, especially with the looming EUDAMED deadline. UDI Connect has streamlined our compliance efforts, enabling us to onboard new markets with greater ease.”

Since its inception in 2019, p36 GmbH has been at the forefront of empowering industry-leading life sciences companies worldwide. By leveraging tailored cloud software solutions like UDI Connect, p36 simplifies regulatory processes and drives digital transformation. The company’s commitment to innovation is a testament to its support for organizations aiming to maintain compliance in a rapidly evolving field. For more details, you can visit udihub.io.

Conclusion

As the medical technology landscape continues to evolve, effective compliance solutions like UDI Connect can make a significant difference. By automating critical processes and enabling seamless integration with existing infrastructures, p36 GmbH is setting a new standard in MedTech compliance, ultimately ensuring that organizations can meet regulatory requirements while minimizing hassle and risk. With such advancements, the future looks brighter for MedTech companies navigating the complexities of compliance.