25. October 2018

KUMAVISION at MEDICA: Ready for ISO 13485: 2016

KUMAVISION presents at the Medica (Hall 15 / Booth F24) the latest version of the ERP industry software for medical device manufacturers and medical device retailers. The Microsoft Dynamics NAV-based industry solution not only delivers all business processes in one solution, but also provides comprehensive support in implementing regulatory requirements such as ISO 13485: 2016, UDI and MDR.

"Numerous new regulatory requirements, global competitive pressure and ever-shorter innovation cycles pose challenging challenges for the medical device and medical device industries, providing the answer with our industry software and supporting our customers with new services," explains Jürgen Baier, Head of Healthcare Solutions at KUMAVISION ,

As integrated business software based on Dynamics NAV (Navision) KUMAVISION ERP combines production, purchasing, quality management, sales, export, CRM, warehousing, logistics, service, field service as well as finance and controlling in an integrated solution. The ERP software for medical device manufacturers and medical device trade This not only lays the foundations for cross-functional workflows, but also for meaningful evaluations. In addition to the increases in efficiency and transparency achieved in this way, compliance-oriented mapping of processes plays a key role.

Regulatory requirements shown

Whether ISO 13485, MRD, UDI, GxP or FDA, medical device manufacturers and medical device retailers must comply with a wide range of standards and regulations. KUMAVISION offers comprehensive support throughout the entire product lifecycle, from purchasing through production to distribution and service. Functionalities such as production control with batch certificate management and end-to-end traceability, integrated quality management including test equipment management and documentation, complaint management with FMEA support or automatic supplier evaluation contribute to compliance with national and international regulations.

Modular consulting packages for validation

One of the most important innovations of ISO 13485: 2016 states that companies have to validate computer-aided systems that they use for their own process control. It is not the software itself that is validated, but the way the software is used in the company. KUMAVISION offers various consulting packages ranging from an inventory to the basic documentation to extensive support throughout the entire validation process. "With our consulting packages, we relieve our customers in a complex field of action, which also contributes to our own certification to ISO 9001, which companies can use to make their own validation easier," says Baier. In addition, the ERP specialist also advises on other standards such as ISO TR 800002 2, MDR, GAMP 5 and MDSAP.

Best Practice as standard

KUMAVISION ERP already delivers proven best practice processes via 200 that take the industry-specific features into account. "Our ERP experience of more than 20 years with around 1.600 successful projects and the know-how of our consultants flow into the development.The close dialogue with customers and the industry guarantees real practical orientation that also includes future topics," Baier says Concept behind the industry software. The processes custom-made for medical technology manufacturers and medical device trade avoid time-consuming individual developments, enabling companies to significantly accelerate the introduction of industry software. The continuous development of the solution creates investment and future security.


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