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

How our product addresses your challenges

Your challenge
Our solution
Your challenge
Regulatory requirements and documentation obligations increase manual workload and create unnecessary sources of error in your processes.
Our 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.
Our 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.
Our 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.
Our 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.
Our 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.
Our solution
ERP-QM integration: CAPA, audit and deviation processes are triggered 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.
Our 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.

Functions – 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 and production through 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 trail Electronic records and approvals for GxP-critical processes are legally compliant and fully traceable.

5.

Ready-to-start validation package according to GAMP5 & ANNEX 11 Prebuilt, field-tested validation templates, automated tests and digital assets to manage validation activities accelerate computer system validation.

6.

Connector to the QM platform (COSMO M365 Quality Management) for CAPA, deviation and audit workflows ERP events trigger QM processes and enable rapid root cause analysis and transparent quality processes.

7.

Intercompany automation for multi-site scenarios Automated purchasing, inventory and invoicing processes across locations and legal entities.

8.

Flexible production methods for equipment and device manufacturing and the production of medical devices Discrete manufacturing is supported with product data management, BOMs and routings; process manufacturing is supported with recipes – including customer-specific configurations.

9.

Standardized interfaces: EDI, REST APIs, CAD-PLM, PIM, labeling Seamless integration into third-party systems and the Microsoft product ecosystem.

Take a look – see how the system works in practice

Spotlight: COSMO Life Sciences

Spotlight: COSMO Life Sciences

COSMO CONSULT – your partner for a secure digital ERP industry solution for the MedTech sector

An ERP project in MedTech requires experience and deep industry know-how. COSMO CONSULT supports you from process analysis through implementation all the way to final software validation – with a team that knows the regulatory requirements and process standards of the industry inside out.

We help you with rollout, training and support and make sure your processes are mapped in the best possible way. Our experts work with you to firmly anchor digitalization and compliance in your organization. Get in touch – we look forward to your challenges.

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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 the central data foundation for all business processes. Because all data is managed centrally and consistently, there are no media breaks between 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. This gives you end-to-end data management and automated workflows.

A connector to the quality management platform (COSMO M365 Quality Management), interfaces to label printing and the option to integrate additional third-party systems provide maximum flexibility and future readiness. Your company stays agile and adaptable.

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COSMO ERP MedTech Manufacturing | MedTech ERP