The ERP solution - tailored to your needs

ERP software for medical technology manufacturers

KUMAVISION is the tailor-made ERP solution for medical technology. The integrated ERP software based on Microsoft Dynamics NAV has been specially developed for the industry-specific requirements of medical technology manufacturers. The modern ERP industry solution forms the company-wide basis for the highest product and process quality. It simplifies the fulfillment of regulatory requirements, improves the internal workflow and provides exact figures. And earn your initial investment in the shortest possible time.

Integrated ERP solution for greater competitiveness

The ERP industry software for all medical technology manufacturers already covers the industry-typical processes for production, external production, quality management, trade, export, CRM, logistics, maintenance, service and finance as standard. The field service is integrated directly into the processes via mobile tablet terminals. All processes lead to integrated financial accounting. Management keeps track of all business transactions and is always able to make informed decisions.

What our customers say

  • KUMAVISION helps us with a variety of functionalities to optimize and lean work and to minimize error rates. Our processes have become much faster and more efficient.

    Freddy Fuchs, Production Manager, Schiller AG
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Benefits for medical technology with KUMAVISION ERP

  • Business-oriented, cross-departmental evaluations and reports at the click of a mouse
  • Optimized production planning and control (PPS) with industry-specific features such as sterilization orders, batch-free production, third-party production
  • Compliance-compatible processes (MPG, ElektroG, ISO, GMG, FDA, RoHS, UDI, etc.) as well as serial and batch number tracking of components and products
  • Audit Trail (mandatory field check, workflows, approval processes, logging changes)
  • Distinct quality management through freely definable inspection plans and integrated inspection equipment management - including supplier evaluation
  • Professional handling of service, repairs and complaints for more customer satisfaction
  • Shorter delivery times and less capital tied up in the warehouse thanks to intelligent logistics concepts (commission and consignment warehouses, pool and case flat rate equipment ...)
  • Efficient data exchange via EDIFACT, openTRANS, XML
  • Support of the validation according to DIN EN ISO / 21CFR820 and GAMP5
  • Intrastat message and summary message
  • Expowin, ATLAS, sanction check (optional)
    Operating data and personnel time recording (optional)

Time is short: The ISO 13485: 2016 is here!

With the new ISO 13485: 2016, medical technology companies are facing serious changes, as the state regulation requires new processes, new product classifications and official validation - by November 2019 at the latest.

It is essential to comply with precise regulations for the design of workflows and processes. This also applies to the enterprise software that controls these processes. The good news: KUMAVISION has already adapted its industry software for medical technology to these new regulations and has once again expanded its already extensive range of functions. In addition, KUMAVISION supports companies in implementing the regulatory requirements of ISO, MDR, etc. and helps to implement the specifications required for validation.

The ERP software from KUMAVISION is well prepared for the new regulatory requirements:

  • 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
  • Risk and Complaint Management (FMEA)
  • Integrated 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

With the combination of ERP industry software + comprehensive consulting, your company benefits from the innovations of the ISO 13485: 2016 and the associated revision and digitization of processes and workflows: processes become more efficient and competitiveness can be further increased.

Everything you want to know. Everything you need.

KUMAVISION's ERP solutions are tailor-made for your role in the company: Whether it's management, project management, purchasing, financial management and controlling, marketing and sales or customer service: find out in our factsheet which advantages KUMAVISION offers you.

Factsheet_Medizintechnik_KUMAVISION.png

The best ERP for medical technology

KUMAVISION's ERP industry software has been honored as the "ERP system of the year 2017" in the medical technology category.

The jury's reasoning: The software solution optimally covers the requirements of medical technology and offers an integrated ERP solution with numerous best-practice processes and a user-oriented role function for medical technology manufacturers and dealers - precisely tailored to their needs.

In addition, features such as comprehensive compliance support (ISO, MDR, GMP or FDA), integrated quality management, risk and complaint management, supplier evaluation, tracking of serial and batch numbers, UDI-compliant labels or the electronic device file support companies in complying with regulatory requirements.

Logo ERP system of the year

ERP industry functions and business processes for medical technology manufacturers

KUMAVISION ERP is the perfectly coordinated ERP software for medical technology manufacturers. Numerous tried-and-tested industry-specific functions ensure well thought-out business processes and therefore greater competitiveness.

Finance and Controlling

All relevant data at the push of a button! With the ERP software for medical technology and the healthcare market, costs and revenues can be broken down transparently and comprehensibly down to the individual process, key figures and evaluations can be easily retrieved and visualized at any time - including BI connection.

Quality management

Increase product quality and customer satisfaction. The ERP industry software from KUMAVISION offers quality management across the entire process chain: from goods receipt with supplier evaluation to production, logistics and service.

Compliance and traceability

KUMAVISION ERP supports medical device manufacturers in meeting with compliance regulations (FDA, MPG, GAMP5): complete traceability, batch production, serial and batch number management, electronic device records, audit trail, etc.

Warehousing and Logistics

More throughput, less capital commitment - KUMAVISION sustainably optimizes warehouse and logistics and offers scanner connection, multi-level storage and retrieval, multi-order picking, warehouse zone management, label printing, shipping connection.

External production

Benefit from the advantages of the extended workbench: Whether external production of parts, assemblies or sterilization orders or supplier evaluation: KUMAVISION simplifies the flexible cooperation with specialized partners.

Integrated solution

KUMAVISION combines professional merchandise management, production, recipe management, modern CRM with field service integration and complete financial accounting with all relevant industry functions in an ERP software.

Electronic Data Interchange (EDI)

The electronic exchange of business documents (EDI) saves time, avoids mistakes and increases customer loyalty. The ERP software supports standard formats such as EDIFACT as well as the exchange with health insurances and marketplaces such as wheel IT and GHX.

Future security

The ERP software for medical technology is based on the globally used standard software Microsoft Dynamics NAV, which is continuously being further developed by Microsoft. This gives you access to the latest technologies at all times.

Service & Complaint Management

Manage service and complaints quickly and efficiently. KUMAVISION offers process-controlled, multi-level processes and forms the return of the goods, replacement, repair, crediting or clarification of a matter

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References

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  • When people suffer from hearing loss, auric hearing systems are in demand. The company has been developing, producing and selling for over 20 years...
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  • Bentley Innomed develops, manufactures and markets products for the minimally invasive treatment of vascular disease. KUMAVISION ERP enables a consistent...
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  • Hain Lifescience manufactures and supplies laboratories worldwide with in-vitro diagnostics. The simple user guidance and the good scalability as well as the...
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  • ORTHEG, a purchasing cooperative for medical supplies, orthopedic workshops and orthopedic footwear technicians, handles trade with KUMAVISION ERP.
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Best Practice with KUMAVISION

Profit from

  • Over 200 Best Practice Processes in the ERP Software
  • Easy adjustment via parameters
  • Interactive documentation with training function
  • Tried and tested procedures from practice
  • Development in dialogue with users and decision makers
  • Fast training of new employees

Unique Device Identification (UDI)

UDI compliant labels

All UDI data directly from the ERP software

  • FDA and MPG compliant product labeling
  • Master data maintenance (article and manufacturer designations, storage conditions, sterilization procedures, lot sizes, etc.)
  • Automatic generation of variable data (serial and batch number, expiry date etc.)
  • UDI-compliant product labeling
  • Label printing (NiceLabel required)
  • Data export for GUDID message
deenit
Contact
Your contact person
Siegfried Kratsch

Siegfried Kratsch

+49 7544 966-200