Regulatory Processes as a Springboard for Greater Efficiency

The focus of the trade fair appearance at MedicalMountains (Hall 3, Stand 3-216) is the ERP software KUMAVISION medtec365. The industry software, based on Microsoft Dynamics 365, combines more than 400 best-practice reference processes for medical technology and maps the complex process landscape in an integrated solution – from purchasing and production to quality management, regulation, and documentation.

In addition to quality control, complaint management, and CAPA, UDI and EUDAMED/GUDID processes are also fully integrated. An integrated document management system (DMS) also ensures the audit-proof filing of documents and supports the management and monitoring of certificates of conformity, supplier certificates, and other regulatorily relevant documents.

"KUMAVISION medtec365 enables medical technology manufacturers to map the entire product lifecycle in a single software solution. This integrated approach creates transparent key figures at all times on the one hand, and forms the basis for the consistent automation of end-to-end processes and thus ultimately a noticeable and sustainable relief for employees," explains Wolfgang Renner, Sales Division Manager Healthcare at KUMAVISION.

Comprehensive EUDAMED Support

The digital product registration in the EUDAMED database, which will be mandatory from May 28, 2026, presents medical technology companies with the task of providing extensive data completely correctly and in XML format. KUMAVISION medtec365 integrates UDI compliance directly into the process landscape and enables a consistently digital and process-reliable mapping of EUDAMED requirements:

• Centralized master data maintenance: Validated data storage specifically for EUDAMED and GUDID.
• Automated XML export: Direct digital transmission from the ERP system without manual detours.
• Integrated label logistics: UDI generation and label printing (via NiceLabel/BarTender) directly from the process.
• Seamless traceability: GTIN management and tracking down to serial number level for maximum audit security.

"Our claim is not only to ensure compliance but also to use it as a lever for greater efficiency. Automation not only enables scaling of the business but also opens up valuable space for innovation for companies," says Wolfgang Renner.

Compliance Integrated as Standard

KUMAVISION focuses on auditable, audit-proof processes. KUMAVISION medtec365 supports medical technology manufacturers in complying with relevant regulations such as DIN EN ISO 13485, MDR & IVDR, FDA 21 CFR part 820 and part 11. Functions such as full traceability at serial and batch level, transparent process documentation, supplier evaluation, complaint management, and CAPA are integrated as standard. Due to the close networking of QM, QA, and QC, the use of additional external QM systems can be avoided in many cases.

In the development of the ERP industry software, KUMAVISION combines ISO 9001 certified quality management with test automation: "The consistent use of automated software tests enables medical technology companies for the first time to use the full potential of modern cloud solutions," explains Renner. "Monthly updates provide valuable innovation impulses and undergo extensive test routines beforehand, so our customers work at all times with a system that is as up-to-date as it is validatable."

AI and Microsoft Copilot Firmly Anchored in the Standard

A particular highlight is the standard use of Artificial Intelligence directly in the ERP software. Additional tools or interfaces are not required. Through the use of Microsoft Copilot and specific AI agents, employees are specifically relieved of time-consuming routine tasks. These include, among other things, the automatic filling of fields, the assignment of electronic documents, or the analysis of lists.

With the new Agent Builder in the industry software, companies can also create their own AI agents for recurring processes that take over these tasks permanently and reliably in the background. Companies benefit from both the Microsoft standard and specific AI extensions from KUMAVISION that are specially tailored to the requirements of the medical technology industry. KUMAVISION will be exhibiting at MedtecLIVE 2026 at the joint stand of MedicalMountains in Hall 3, Stand 3-216.

KUMAVISION AG

KUMAVISION is a specialist for ERP and CRM software from the cloud based on Microsoft Dynamics 365. For over 30 years, KUMAVISION has been realizing and implementing industry-specific software solutions for the manufacturing industry, wholesale and retail, service, medical technology, and the healthcare market. Business intelligence, DMS and workflow solutions as well as consulting offers and services around digital transformation complement the portfolio. Customers include medium-sized companies as well as international corporations.

The KUMAVISION Group is one of the world's leading integration partners for Microsoft Dynamics and employs over 1,000 people at 29 locations in Germany, Italy, Austria, and Switzerland. Total sales in 2025 were around 157 million euros. The KUMAVISION Group includes the activities of KUMAVISION AG (D-A-CH) and the EOS Solutions Group (I). Further information on the KUMAVISION AG website at: www.kumavision.com