Strict regulatory requirements, cost-intensive manufacturing processes, and high quality standards for medical technology products make digitalization in the medical technology industry a particular challenge. At KUMAVISION, we meet this challenge with specialist knowledge and best practices.

Our KUMAVISION medtec365 solution, based on Microsoft Dynamics 365 Business Central, is optimized for the needs of medical technology—whether manufacturing, trade, or service processing. It includes numerous industry-specific functions and links all your processes together.

Note: This app is not tested against the local regulations of the respective country and can only be deployed in cooperation with KUMAVISION. For Germany a tested country version is available.

Your Advantages with medtec365

• Compliance with regulatory requirements: our fully validatable software provides you with optimal support in complying with guidelines and standards such as ISO 13485:2016, MDR, GAMP5, UDI, MDSAP, FDA, etc.

• Integrated solution: instead of incompatible isolated applications, you will find all functions centrally in one system (production/merchandise management/QM, etc.).
• Specialist know-how: the specialist knowledge and wealth of experience of our industry experts bundled in one app

• Efficiency through automation: reduced administrative effort and relief for your employees in routine tasks save time and money.

• Best practice: optimized and well-thought-out processes based on KUMAVISION's many years of project experience in the sensitive market environment of the medical technology industry.

• Security standards: robust security features for sensitive data in a centralized Microsoft 365 environment

• Future-proof and competitive: a flexible platform that is always up to date and can be adapted to changing business requirements

Highlights

• Dual control principle with approval workflows for master and transaction data

• Integrated quality management with test plans

• Risk and complaint management (FMEA/CAPA)

• MDR module (approval control/document control)

• Automatic supplier evaluation

• Seamless traceability of serial and batch numbers, shelf life and sterility data (traceability)

• UDI/EUDAMED (data records, label printing, upload management in databases)

• Electronic device file (Medical Device File)

• Audit-proof document management system (DMS)

• Integrated service processing / contract management

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