ERP software for MedTech: Efficient production, end-to-end compliance and validation assurance
The industry solution COSMO ERP MedTech Manufacturing extends Microsoft Dynamics 365 Business Central with specialized features for the MedTech industry. The integrated ERP industry solution for medical technology maps complex production processes and mixed manufacturing methods and consolidates all key regulatory requirements for MedTech of the future on a single platform.
Customer-specific configurations, product data management, batch traceability and serial number tracking, quality assurance, Unique Device Identification (UDI) management, vendor rating and digital approvals are fully integrated. This gives your team maximum transparency plus process and product safety.
With deep integration into Microsoft Dynamics 365 Business Central and seamless connectivity to the COSMO M365 Quality Management platform, you automate compliance processes, reduce manual effort and can rely on a central, trusted database.
The result: efficient workflows, fewer sources of error, and significantly shorter audit preparation times – for medical technology of the future.

Medi-Globe Group
Customer success at a glance

Spotlight: COSMO Life Sciences
End-to-End Validation and Quality Management Integration for the Medical Technology Industry
With our ready-to-start validation package based on GAMP5 and ANNEX 11, you can speed up your computer system validation and reliably meet international standards. Preconfigured validation templates and quick-start packages significantly reduce implementation and validation effort and help you go live faster.
Thanks to the seamless integration of ERP system and quality management platform (COSMO M365 Quality Management), CAPA, audit and deviation processes can be triggered and managed directly within the ERP system. You benefit from transparent workflows, automated documentation, and a central single data source for all regulatory processes. Your MedTech compliance becomes a strategic competitive advantage.
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How COSMO ERP MedTech Manufacturing tackles your challenges

AI and digitalization: Future-proof MedTech with COSMO ERP MedTech Manufacturing
In the MedTech industry, rising market demands and strong cost pressure are the norm. At the same time, companies must maintain their power through innovation. Efficiency becomes a critical competitive factor: artificial intelligence and digital processes are shaping the future of the industry. COSMO ERP MedTech Manufacturing helps you leverage innovative technologies and integrate them securely and according to regulations.
With a focus on AI-powered analytics, automated workflows and compliance, you benefit from efficiency, transparency, and a platform that is continuously evolving. You allows you to stay flexible and continue to meet all regulatory requirements now and in the future – securing your long-term success in the industry.
Features - What's Under the Hood
Integrated UDI data management, label printing and data exchange with GUDID and EUDAMED databases
Unique Device Identification (UDI) data is centrally managed and exported in a standardized way, including label printing
Trace batches and serial numbers across the entire value chain
End-to-end traceability of products, batches, and serial numbers – from goods receipt through production to service
Automated document storage in Microsoft SharePoint Online
Technical documents, specifications, and certificates are linked to ERP data and can be found quickly at any time
21 CFR Part 11-compliant digital approvals and audit trails
Electronic records and approvals for GxP-critical processes are fully compliant and traceable
Ready-to-start validation package according to GAMP5 & ANNEX 11
Prebuilt, field-tested validation templates, automated tests, and digital assets for managing validation activities accelerate computer system validation
Prebuilt, field-tested validation templates, automated tests, and digital assets for managing validation activities accelerate computer system validation
Prebuilt, field-tested validation templates, automated tests, and digital assets for managing validation activities accelerate computer system validation
Prebuilt, field-tested validation templates, automated tests, and digital assets for managing validation activities accelerate computer system validation
Automated purchasing, inventory and invoicing processes across locations and companies
Automated purchasing, inventory and invoicing processes across locations and companies
Automated purchasing, inventory and invoicing processes across locations and companies
Standardized interfaces: EDI, REST APIs, CAD-PLM, PIM, labeling
Seamless integration into third-party systems and the Microsoft product ecosystem
Take a look—this is how the system works in practice

Spotlight: COSMO Life Sciences
Spotlight: COSMO Life Sciences

Our ERP for MedTech – fully integrated with Microsoft Dynamics 365 Business Central
COSMO ERP MedTech Manufacturing is seamlessly integrated with Microsoft Dynamics 365 Business Central and uses a central database for all business processes. Because all data is managed centrally and consistently, there are no media disruptions between the lab, purchasing, sales, production, quality assurance, warehouse, and service.
You can also directly connect other solutions from the Microsoft product portfolio – such as Microsoft SharePoint Online, Microsoft Teams or the Microsoft Power Platform allowing you to benefit from end-to-end data management and automated workflows.
A connector to the quality management platform (COSMO M365 Quality Management), interfaces for label printing, and the option to integrate additional third-party systems provide maximum flexibility and future-proofing. This keeps your company agile and adaptable.

COSMO CONSULT – your partner for a secure digital ERP solution for the MedTech sector
An ERP project in MedTech requires experience and industry expertise COSMO CONSULT supports you every step of the way - from analyzing your processes to implementation and final software validation. Our team understands the regulatory requirements and process standards specific to the MedTech industry ensuring a smooth and compliant rollout.
We support you with rollout, training and support of your solution, ensuring that your processes are mapped optimally. Our experts work with you to firmly anchor digitalization and compliance sustainably in your organization. Contact us – we look forward to tackling your challenges.
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