ERP software for medical technology

Easily implement new business models such as pay-per-use or predictive maintenance with the ERP software from KUMAVISION. With Azure IoT, the Microsoft technology platform offers you extensive IoT integration to connect devices at customers or machines in production with the industry software from a variety of manufacturers.

• Transparent manufacturing
• QS/QM documentation
• Pay per use
• Predictive Maintenance
• Monitoring of transport and storage conditions

The industry software manages and generates all UDI-relevant information such as Device Identifier (DI) and Production Identifier (PI). While the DI is a fixed, ISO-based code for identifying the article and the manufacturer, variable data such as serial and batch numbers or the expiry date are stored in the PI by the ERP system.

UDI-compliant labels can be output directly from the industry software via NiceLabel. In addition to plain text, machine-readable 1D and 2D barcodes in the GS1 and HIBC standard are supported.

In addition, the upload to the GUDID database (Global Unique Device Identification Database) is possible directly from the ERP software.

• Legally binding marking
• Automated Unique Device Identifier (UDI) workflows
• Flexible label printing or direct marking
• Integrated GUDID upload
• No double data maintenance, no media breaks

The document management system (DMS), which is seamlessly integrated into the ERP software, supports and relieves companies when dealing with documents and data of all kinds. Documents can be easily classified using a matrix and directly assigned to products or product lines. The entire product life cycle is taken into account and mapped in the DMS.

The documents required for audits can be made available practically at the touch of a button. In addition, KUMAVISION will offer automated uploading to online portals for remote audits and approvals.

• DMS as a single point of view for all documents in the company
• Flexible workflows for approval processes, updating and distribution of documents in all areas of the company
• System-controlled administration of drawings, approval documents, certificates of conformity, proof of suppliers, certificates and operating instructions
• Ensuring traceable assignment down to component level over the entire product life cycle in the DMS
• Management of test orders, visit reports, proof of repairs or documentation as part of FMEA and CAPA measures
• Automated output, e.g. B. Delivery note including proof of conformity and QS test results

Whether production, purchasing, sales, sales, development, logistics or service: KUMAVISION supports you in complying with the requirements of the Medical Device Regulation (MDR). The industry software takes the entire product life cycle into account. 

The numerous compliance and QS-relevant functions collect all the necessary data in a central system. Intelligent assistants safely guide the user through the process and data acquisition, automated workflows relieve the user of time-consuming routine tasks.

The digital master file (Device Master Record/Medical Device File) collects all documents for the respective product via the DMS integrated in the industry software.

• Digital master file including audit-proof filing and audit trail
• Administration and monitoring of approvals
• Automatic reminder before expiry date

Use the advantages of a mobile field service connection with apps. 

• Simplified coordination of office and field service
• Digital documentation including signature
• Full access to customer and device history
• Direct initiation of follow-up processes (ordering of spare parts, delivery of replacement devices, etc.)
• Efficient resource planning
• Offline-enabled apps for tablets and smartphones
• Mobile recording of working hours

The ERP software offers complete traceability of serial and batch numbers over the entire product life cycle. Medical device manufacturers and medical device dealers benefit from traceability down to the component level. 

Serial and batch numbers are managed or generated by the ERP system. Complex scenarios such as "device in device" can also be mapped if, for example, a device contains several components that require serial numbers. Traceability when replacing components as part of repairs

The optional use of scanners accelerates the recording of batch and serial numbers and increases the process quality in production as well as incoming and outgoing goods. In addition to labels (NiceLabel, Bartender) and delivery notes, etc., the control of solutions for direct marking is also possible during output.

Modern CRM solutions not only make it possible to digitize previously paper-based processes in sales, marketing and service, but also to strengthen customer relationships, relieve employees of time-consuming routine tasks and improve corporate management through a uniform process landscape.

• Central retrieval of all customer interactions
• Control and evaluation of all sales activities
• Simple target group determination for marketing campaigns
• Control of service activities in the field
• Management of internal training and certifications
• Planning, implementation and evaluation of events of all kinds

Make operational and strategic decisions based on current and reliable key figures.
KUMAVISION offers you business intelligence solutions based on Microsoft that are precisely tailored to the requirements of the medical technology industry Power BI. Industry-specific key figures, reports and evaluations are already included.
Companies can quickly start with a business intelligence solution and expand or adapt it individually.