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05 October 2022

MEDICA 2022: Future through digitization

Simplified audits without any frights, integrated document management (DMS) and data-based business models: The industry software specialist KUMAVISION will be showing at MEDICA (Hall 15 / Stand K16) how medical device manufacturers and retailers can use KUMAVISION to securely implement regulatory requirements, keep an eye on the entire product life cycle and use the opportunities of online platforms with clinical and medical data. In addition to increasing internal transparency and efficiency with the ERP industry software for medical technology, KUMAVISION focuses on the conception and implementation of future-proof IT and digitization strategies with new consulting and service offers.

Diagram 2 PM Medica

"With our industry software, companies already receive consistent, integrated support out-of-the-box to master the regulatory requirements of MDR, ISO 13485 and FDA," explains Wolfgang Renner, Head of Medical Technology and Healthcare Market. The industry software specialist has further expanded the inclusion of the document management system (DMS). Companies manage e.g. B. Drawings, approval documents, certificates of conformity, supplier verifications, certificates or operating instructions in a central location, which ensures a traceable assignment down to the component level. Documents flow into the document management system over the entire product life cycle, for example test orders, visit reports, proof of repairs or documentation as part of FMEA and CAPA measures. KUMAVISION thus establishes a single point of view that includes all areas of the company. The documents required for audits can be made available practically at the push of a button. In addition, KUMAVISION will offer automated uploading to online portals for remote audits and approvals.

Digital future with data-driven business models

KUMAVISION supports the digital transformation of the industry with individual solutions and has further expanded the team of consultants. The design and implementation of the IT and digitization strategy are implemented together with customers based on the Catalyst method, which ensures a 360-degree view of the company, strategy and technology. The company does not just look at the area of ​​process optimization with business software. “We see at Medical Clouds that provide clinical and medical data, there is enormous potential for the industry to strengthen its competitiveness and thus future security," explains Andrea Fiedler, consultant for digitization in medical technology at KUMAVISION. The company is pursuing the approach of establishing models together with medical device manufacturers in which device data, patient behavior and therapy results are evaluated anonymously in order to further develop products in a targeted manner, simplify operation and improve the energy efficiency of devices. KUMAVISION is therefore involved as a partner in medical data platforms such as AIQNET: "After handover to the clinic, practice or patient, medical products and devices become a black box for the manufacturer. With Medical CloudHere we gain valuable insights from which everyone involved in healthcare will benefit in the long term,” comments Fiedler.

Many tasks, one solution

Whether regulatory requirements (MDR, ISO 13485, UDI/EUDAMED, FDA) or continuous QM/QS support over the entire product life cycle, whether FMEA analyzes and CAPA measures or audit trail, whether batch-specific production or serial and batch number tracking up to Component level: The KUMAVISION industry software is precisely tailored to the requirements of medical device manufacturers and dealers. KUMAVISION has the ERP standard software for this Microsoft Dynamics 365 Business Central (formerly Navision) has been expanded to include over 350 industry-specific best practice cases with several thousand functions, workflows and evaluations. In addition to the ERP functionalities, the Microsoft technology platform also includes CRM solutions for sales, service and marketing, business intelligence applications, components for IoT and AI and applications for collaboration such as teams and Outlook. “The wide range of solutions is unique in the world. The integration on a platform gives our customers real competitive advantages, since there are no media breaks or data silos," comments Renner. In addition to the ERP industry software, KUMAVISION offers other applications that are specially preconfigured for medical technology. The SmartStart approach simplifies and accelerates the introduction, companies get direct access to numerous best practice processes that have proven themselves successfully in the industry. In the Power BI business intelligence application, for example, KUMAVISION has already prepared the key figures, reports and dashboards typical of the industry.

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