ERP for MedTech: Reliable processes with COSMO ERP MedTech Manufacturing

Optimize your MedTech process landscape – from regulatory requirements to efficient production with Dynamics 365 Business Central

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

30 %reduction in audit preparation time
30 %reduction in batch / serial number release time
40 %reduction in validation effort

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

Your Challenge
Product Solution
Your Challenge
Regulatory requirements and documentation obligations increase manual workload and create unnecessary sources of error in your processes.
Product Solution
Automated compliance: Integrated functionalities such as UDI management and digital process approvals reliably meet MDR, FDA and ISO 13485 requirements.
Your Challenge
Fragmented data sources and lack of visibility waste valuable time and make audit preparation difficult.
Product Solution
Central data foundation: All relevant information along the value chain is consolidated in Microsoft Dynamics 365 Business Central and is available at any time.
Your Challenge
Error-prone manual processes for product labeling and UDI assignment lead to high inspection and correction effort.
Product Solution
Digital workflows: Automated UDI creation and integrated label printing with full audit trail capabilities minimize errors while increasing process and product safety.
Your Challenge
The significant validation effort for initial validation and change management increases costs and slows down processes.
Product Solution
Ready-to-start validation: Prebuilt, field-tested validation templates, automated tests, and digital assets to manage validation activities cut time and costs. This can reduce software validation time in MedTech by up to 40%.
Your Challenge
Product recalls and quality deviations create significant risks, while lack of transparency in the supply chain creates safety issues and high costs.
Product Solution
Complete serial number and batch management: Continuous quality control along the entire value chain ensures maximum product safety and strengthens your customers’ trust.
Your Challenge
Lack of integration between ERP system and quality management leads to a disconnect between quality management, documentation and process reality.
Product Solution
ERP-QM integration: CAPA, audit and deviation processes are initiated and accelerated directly from the ERP system via a connector.
Your Challenge
A lack of process integration for mixed manufacturing methods makes it impossible to map complex MedTech production processes.
Product Solution
Support for hybrid manufacturing methods and customer-specific configurations: Mixed manufacturing methods (discrete manufacturing and process manufacturing) and customer-specific configurations can be mapped in a single ERP system based on Microsoft Dynamics 365 Business Central.

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

1.

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

2.

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

3.

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

4.

21 CFR Part 11-compliant digital approvals and audit trails

Electronic records and approvals for GxP-critical processes are fully compliant and traceable

5.

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

6.

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

7.

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

8.

Automated purchasing, inventory and invoicing processes across locations and companies

Automated purchasing, inventory and invoicing processes across locations and companies

9.

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

Enlarge Image

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. 

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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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Recent Awards

6x Microsoft Solutions Partner
Awarded Microsoft's highest seal of quality in all categories.

6x Microsoft Solutions Partner

Awarded Microsoft's highest seal of quality in all categories.

Among the top 1% of partners worldwide every year since 2014.

Microsoft Dynamics Inner Circle

Among the top 1% of partners worldwide every year since 2014.

Among the top 0.4% of all employers in Germany.

Top-Arbeitgeber

Among the top 0.4% of all employers in Germany.

Leading Data & Analytics Partner: 11× Leader, multiple #1 rankings, and a 100% recommendation rate.

BARC-Study 2026

Leading Data & Analytics Partner: 11× Leader, multiple #1 rankings, and a 100% recommendation rate.

Our software is already being used successfully by these companies

Frequently Asked Questions

Your expert for COSMO ERP MedTech Manufacturing

Andy Buchmann ist Ihr Ansprechpartner für digitale Medizintechnik-Prozesse bei COSMO CONSULT. Als Branchenexperte begleitet er Sie von der ersten Analyse bis zur erfolgreichen Implementierung und Validierung Ihrer ERP-Lösung. Profitieren Sie von seiner Erfahrung und praxisnahen Beratung – sprechen Sie ihn gerne direkt an. 

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