KUMAVISION medtec365 combines the advantages of a flexible SaaS solution with the functionality of a proven ERP industry solution for medical technology.
With KUMAVISION med365 stands the tried and tested ERP industry solution from KUMAVISION for medical device manufacturers and medical device dealers now available as a modern SaaS solution. The ERP industry software maps all areas of the company in an integrated software solution and brings with it numerous best-practice functions for companies in the regulated environment. KUMAVISION medtec365 based on the technology platform Microsoft Dynamics 365, which, in addition to the ERP software, also includes other business applications such as CRM, business intelligence and DMS. Companies can flexibly combine these with each other and thus increase their competitiveness with an agile, modern IT landscape.
“The concept of Software-as-a-Service (SaaS) is much more than just a technological perspective. SaaS enables medical technology companies to react quickly to changing market requirements or in the regulated environment and to implement new business models promptly," explains Wolfgang Renner, Head of Healthcare Solutions, KUMAVISION AG. With the SaaS solution medtec365 KUMAVISION provides and operates the Cloud thus replaces local operation (on-premises) in the company itself. The industry software medtec365 is always kept up to date by automatic updates in the background. Short innovation cycles from KUMAVISION and Microsoft ensure that customers have direct access to new functions and technologies. Further advantages are the simple scalability, worldwide availability and the relief of the IT department. “Previously, companies only updated their ERP software every four to six years. medtec365 is automatically updated on a regular basis and thus strengthens the competitiveness of our customers,” comments Renner. Thanks to automated tests and the Computer Software Assurance (CSA) approach, the updates are traded and documented in compliance with the standard, which significantly reduces the effort involved in validation.
Reach your goal faster with best practice
Whether regulatory requirements (MDR, ISO 13485, EUDAMED, FDA) or continuous QM/QS support over the entire product life cycle, whether FMEA risk analyzes and CAPA measures or audit trail/traceability, 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 has been expanded to include over 350 industry-specific best practice cases with several thousand functions, workflows and evaluations. The SaaS solution, which is tailored to the regulated environment, is also fully validatable. Medical device manufacturers and medical device dealers thus receive a solution that is preconfigured and set up for the industry: Since time-consuming and costly adjustments are no longer necessary, companies can quickly use medtec365 work productively. SmartStart packages developed by KUMAVISION also simplify and accelerate project implementation. “In today's highly dynamic market environment, companies simply no longer have time for lengthy software projects. With the SaaS solution medtec365 we enable an extremely short time-to-market,” says Renner.
Ready for the regulated environment
The DMS integrated into the ERP industry software simplifies the mapping of national and international standards and regulations (MDR, ISO 13485, FDA). 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, certificates, proof of repairs or documentation as part of FMEA and CAPA measures. Documents can be output under system control, for example when printing shipping documents, the appropriate instructions or certificate of conformity can be printed out automatically. During audits, the industry software provides all relevant information practically at the touch of a button. KUMAVISION has also expanded data exchange with databases and platforms. The automated transfer of data to the EUDAMED database, including error management, has been successfully implemented in pilot projects. The connection to online marketplaces is facilitated by the use of a universal data hub, as is the transmission of data and documents for online audits.
Future-proof technology platform
The technology platform Microsoft Dynamics 365 offers much more than just ERP. It also includes, for example, CRM solutions for sales, marketing, customer service and field service, business intelligence applications, workflow and automation solutions, and Microsoft 365, Teams, IoT, AI and more Cloud-Services. All applications can be flexibly combined with each other, the common database avoids data silos and interface problems. Here, too, KUMAVISION offers SmartStart packages that simplify the introduction of new solutions. This results in numerous advantages for companies: Dynamics 365 not only increases efficiency in day-to-day business through seamlessly integrated applications, but also supports management in strategic and operational decisions with transparent key figures. At the same time, companies use the Modern Workplace concept to position themselves as attractive employers.