Mastering challenges

ERP software for medical technology

Microsoft AppSource

Safely in the future

Stricter regulatory requirements, increasing international competition, ongoing shortage of skilled workers, new customer requirements, rapid technological change: in medical technology you are confronted with numerous challenges every day.

The ERP industry software from KUMAVISION supports you not only in making your day-to-day business more efficient, but also in successfully driving growth and thus the future security of your company.

  • Compliant at all times: ISO 9001-certified, validatable Validable according to MDR and ISO 13485, standard-compliant release management
  • Best Practice: 350+ industry-specific functions and workflows
  • Integrated solution: Inventory management, production, warehouse & logistics, QS/QM, service and financial accounting in one software
  • Future-proof: The technology platform Microsoft Dynamics 365 enables easy expansion with CRM solutions (sales, service, marketing), business intelligence, Office and IoT - without any data silos.

NEW: The KUMAVISION quality platform

ERP software, ECM/DMS and QM processes on one platform

  • Digitalization of the entire product life cycle
  • Secure mapping of QM, QS and QK
  • Ready for MDR, ISO 13485, FDA, UDI
  • Digital storage of all documents, receipts, evidence and certificates
  • Full integration with Microsoft 365, e.g. B. Outlook and Teams
sqm platform medical technology

KUMAVISION: The gold standard for medical technology

More efficiency

More efficiency

Automated processes relieve your employees of time-consuming routine tasks. Complete all tasks in one software - without any data silos. Connect customers and suppliers electronically.

More best practice

More best practice

Use the gold standard for medical technology. More than 300 best-practice processes avoid time-consuming and costly individual developments and thus enable a short time-to-value.

More transparency

More transparency

Control your company with key figures in real time. Stay informed at all times. Recognize impending bottlenecks in advance so that you can take action in good time.

More compliance

More compliance

Whether ISO 13485, MDR or FDA: With ERP industry software from KUMAVISION, you can reliably map normative requirements, relieve your employees of time-consuming routine tasks and are optimally prepared for audits.

More future

More future

Open up new markets with new business models such as pay-per-use or predictive maintenance. Respond flexibly to changing customer requirements. Get anytime access to leading Microsoft technology.

More possibilities

More possibilities

DMS solutions including workflow management, CRM for service, sales and marketing, business intelligence, mobile apps, IoT ... With KUMAVISION, all options are open to you. Fast, easy, industry-oriented.

Just everything. Everything easy.

The ERP industry software from KUMAVISION is fully validatable and supports you company-wide in meeting regulatory requirements such as ISO 13485:2016, MDR, GAMP5, UDI, MDSAP, FDA, ....
  • Compliance support (ISO, MDR, GMP or FDA)
  • Graded user authorization concept
  • Four eyes principle with approval workflows
  • Audit Trail (complete tracking of changes)
  • Quality Management (QM)
  • Risk and Complaint Management (FMEA)
  • Integrated, audit-proof document management system (DMS)
  • Supplier Evaluation
  • Tracing of serial and batch numbers (traceability)
  • Unique Device Identification (records, label printing, upload in GUDID)
  • Electronic device file (Medical Device File)
  • Validation of KUMAVISION software and development processes
In addition, we support you in the validation of your company and your processes according to national and international standards.
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.

60% more sales without additional staff

Logo SQ Products AG

How the Swiss medical device manufacturer SQ Products AG increases efficiency and growth with ERP industry software from KUMAVISION

"Last year we increased our sales by 60%, and sales are expected to increase further this year. The KUMAVISION industry software has proven to be an excellent solution for all of our needs: in the areas of supply chain (purchasing, production planning, production control, shipping processing ) the growth took place without additional staff. KUMAVISION has set up a tailor-made system for us that SQ Products AG will enjoy for a long time to come."

Stephan Locher, IT manager, SQ Products AG

For all areas of the company, for all requirements

Every business area has different requirements for the ERP software. The ERP industry solution from KUMAVISION is not only perfectly tailored to the requirements of the regulated environment, but also brings individual functions, views and evaluations for every role in the company.

Make strategic and operational decisions based on current key figures. Easily implement new business models such as pay-per-use, open up new markets and scale your business:
  • Visualization of all relevant key figures for corporate management
  • Convenient reporting at the push of a button
  • Increased efficiency through automation
  • Mapping of MDR, ISO 13485, UDI, FDA, ...
  • Easy integration of CRM and DMS solutions
  • Future security through Microsoft technology
With KUMAVISION ERP you benefit from continuous processes in production and maximum transparency across all processing steps - for the highest product quality in time and in budget.
  • Optimized production planning and control (PPS)
  • Single and multi-level production orders
  • Parts lists with version management
  • Manufacturing with serial numbers
  • Batch production
  • Traceability across all manufacturing steps
  • External production with provision including sterilization
Quality Assurance
Always compliant, always relaxed: With KUMAVISION ERP you get fully validatable industry software that supports you in complying with international and national standards and regulations.
  • ISO, MDR, GMP, UDI/EUDAMED and FDA support
  • Multi-level test plans and integrated test equipment management
  • Serial and batch number tracking
  • Continuous traceability (traceability)
  • Dedicated access and change rights management
  • Multi-stage approval processes and the four-eyes principle
  • Risk and Complaint Management (FMEA)
  • Audit Trail
  • Automated supplier evaluation
Customer Service
With the ERP solution from KUMAVISION you increase the satisfaction of your customers by managing service inquiries and complaints quickly and efficiently. Typical processes such as the return of goods, replacement delivery or the creation of credit notes are mapped using multi-level processes.

  • Preparation of cost estimates for internal and external repairs
  • Automatic repair pricing
  • Processing of repair contracts
  • Working with repair BOMs (customer / process dependent)
  • Illustration of repair bridges
  • Complaint / complaint management with integrated action control
  • Administration of the service workshop and external processors
  • Technical safety control (STK) and maintenance management
  • Offline service app for efficient collaboration between field and office staff
KUMAVISION ERP provides the sales management with all the basic data for efficient evaluation and the precise control of sales activities.

  • EDI tool for intelligent data exchange with business partners and e-commerce portals (optional)
  • Commission management
  • blanket orders
  • Order entry via customer history and reorder lists
  • Clear sales cockpit
  • Margin check
  • Approval workflows
As an integrated system, the industry solution maps the entire purchasing process and offers a high degree of automation. This saves time and money and increases effectiveness.

  • Automated order proposals
  • Framework agreements
  • Industry-specific pricing
  • Optimized order proposal
  • Invoice verification and delivery reminders
  • Simple return management
  • Clear credit management / debit notes
  • Integrated supplier evaluation
  • Order confirmation management
Finance and Controlling
With the ERP software for medical technology manufacturers, costs and income can be broken down transparently and comprehensibly down to the individual process, and key figures and evaluations can be easily accessed and visualized at any time - including a BI connection.
  • Fully integrated and certified financial accounting
  • Central evaluation of all business processes
  • Inventory evaluation with automatisms for devaluation
  • Sales evaluation at the time of delivery
  • Integrated cost center and cost unit accounting
  • Variable illustration of tax requirements
  • Reading of account statements and advices
  • consolidation
  • XBRL (Extensible Business Reporting Language)
  • Reminder and interest system
  • Domestic and foreign payments
  • IFRS postings
  • Work-in-progress assessments
  • Asset Accounting
Warehousing and Logistics
More throughput, less capital tied up - KUMAVISION optimizes warehouse and logistics sustainably and offers the ideal tools from the scanner connection to multi-level storage and retrieval, multi-order picking, storage zone management and label printing up to the shipping connection.

  • UDI-compliant labeling
  • Barcode-supported warehouse management
  • Mapping of different storage zones and locations with different storage strategies such as free choice of storage location
  • External and consignment warehouse including external property management
  • Different storage and retrieval strategies (e.g. First Expired First Out (FEFO) principle, 2-stage picking)
  • Quality assurance through test orders in incoming goods including test equipment management
  • Connection of shipping service providers such as DHL, TOF, UPS, TNT, DPD and GLS as well as integrated parcel tracking
  • Deadline inventory and permanent inventory
White Paper Medical Technology 2025

Medical technology 2025 – success strategies for the future

In this white paper you will learn ...

  • How to successfully master the challenges in the regulated environment
  • Which possibilities for automation and increase in efficiency a modern industry software for medical technology opens up for you
  • How to implement the requirements of MDR, ISO 13485 and UDI in a compliant and time-saving manner
  • What role business software plays in the development of new business models for the medical technology industry

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KUMAVISION industry software for medical technology

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