Digitalization in medical technology | COSMO CONSULT

Q: Are MDR compliance, ISO 13485, and UDI supported?

COSMO CONSULT consistently maps MDR-relevant processes and ISO 13485-compliant QM procedures.

Q: How do COSMO CONSULT medical technology solutions specifically reduce our validation efforts (CSA/GAMP 5)?

With tried-and-tested templates, preconfigured processes, and clear roles, implementation becomes structured and efficient.

Q: Can existing systems or databases be connected (PLM/PDM, DMS, NiceLabel, EUDAMED/GUDID, EDI)?

COSMO CONSULT offers native integration with Microsoft Dynamics 365 Business Central, Microsoft SharePoint Online, Microsoft Teams, the Microsoft Power Platform, and standardized interfaces to the GUDID/EUDAMED databases, product data management (PDM), document management (DMS), and label printing.

Q: How do COSMO CONSULT medical technology solutions ensure data protection and data security ( , Cloud, 21 CFR Part 11)?

COSMO CONSULT relies on Microsoft Cloud Security, role-based access, and electronic signatures in accordance with 21 CFR Part 11. Audit-proof storage and an integrated audit trail ensure maximum security and compliance.

Q: What are the advantages of integrated quality management (CAPA, deviations, approvals, document control)?

Integrated quality management enables end-to-end processes from deviation to CAPA with clear responsibilities.

Q: How does COSMO CONSULT support AI-assisted analyses for quality and planning?

AI-supported evaluations enable anomaly and pattern recognition, predictive scenarios, and better planning.

Q: What options are available for training, support, and change management—and also for high user acceptance?

Role-based training, practical courses, and accompanying communication promote user-friendliness.

Q: What cost models are possible (cloud operation, terms, scaling)?

Flexible, scalable cloud models and modular expandability offer you full cost control. Prices are offered individually according to your needs and company size.

Medical technology digitization from the market leader: security, compliance, and state-of-the-art AI technology

Digitalization in medical technology is the key to the future success of your company. It creates clarity, security, and scalability for the further development of your business. With Microsoft Dynamics 365 and solutions from COSMO CONSULT, you can connect all areas of your company from product development, manufacturing, quality assurance, and management to delivery and service in a continuous end-to-end process flow.

From now on audit trails, e-signatures, and UDI management are a breeze with traceability at the touch of a button, approvals in minutes, and real-time transparency through AI-supported analyses. The Microsoft Cloud platform, modular implementation, and integrations with industry-standard partner solutions (such as NiceLabel) and central MedTech databases (such as EUDAMED/GUDID) ensure scalability and investment protection. Rely on a future-proof IT architecture and proven confirmation of your product quality.

Challenges in medical technology – how we tackle them

Your Challenge

Product solution

Your Challenge

Increasing regulatory complexity Different regulatory requirements such as MDR, ISO 13485, and FDA must be met simultaneously. Manual processes increase the risk of errors and non-compliance.

Product solution

Validatable compliance processes: COSMO CONSULT integrates MDR, ISO 13485, and FDA requirements directly into Microsoft Dynamics 365. Audit trails, UDI, electronic signatures, and GAMP 5-compliant validation secure your processes.

Your Challenge

Data silos and lack of integration of legacy and third-party systems. Non-networked systems lead to media breaks, scattered or redundant data, and limited data transparency.

Product solution

Consistent data flows: Standardized interfaces to systems such as product data management (PDM), document management (DMS), or label management create consistent data flows. This results in consistent master data and reliable real-time information for informed decisions.

Your Challenge

Cost pressure coupled with the need for innovation. Increasing market demands and cost pressure are difficult to reconcile with maintaining a constant level of innovation.

Product solution

Efficiency through automation: Best practice processes, AI-supported analyses, and automated batch management reduce process costs, ensure consistently high quality, and create scope for research and development.

Your Challenge

UDI management and traceability. Complex requirements for UDI labeling and seamless traceability require integrated processes.

Product solution

Integrated UDI management: COSMO CONSULT enables FDA/EU-compliant UDI processes, NiceLabel connectivity, and export to EUDAMED/GUDID databases for end-to-end transparency and seamless traceability.

Your Challenge

Scalability and IT security. Growing data volumes and increasing security requirements call for a future-proof IT architecture.

Product solution

Microsoft Cloud ERP solution: The scalable platform, security by design, and regular updates guarantee investment protection, GDPR compliance, and an IT architecture that grows with you.

Your Challenge

High validation effort and long approval times. The validation of computer systems (CSV) in accordance with MDR, FDA, or ISO 13485 is complex and time-consuming. Manual checks and paper-based approvals delay projects and increase the risk of compliance violations.

Product solution

COSMO Computer Software Assurance (CSA): Efficient, risk-based software validation with preconfigured validation packages and proven CSA methodology reduces effort by up to 50%. Digital workflows and electronic approvals deliver audit-proof reports in minutes – for compliance and quality.

Your Challenge

Integration of complex manufacturing processes and mixed manufacturing methods. Discrete manufacturing and process manufacturing are difficult to integrate into one system.

Product solution

Support for hybrid manufacturing processes and customer-specific configurations: COSMO CONSULT industry solutions enable mixed manufacturing processes (discrete manufacturing and process manufacturing) and customer-specific configurations based on Microsoft Dynamics 365 Business Central to be mapped into a single ERP system.

Free consultation

Fact check: COSMO's contribution to medical technology digitization in figures

50+

experts for regulated industries (MDR, ISO 13485, GAMP 5)

30+

successful projects in medical technology

10+

years of experience in the MedTech industry

How COSMO CONSULT supports MedTech companies across the entire value chain

Industries where we feel at home

Context slider

Equipment and Apparatus Engineering

In appliance and apparatus engineering, you focus on your customers' wishes. However, constantly growing requirements and the global price war are a challenge for profitability. Digital technologies help you to optimize processes and get closer to your customers.

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Plastics Industry

Success in the plastics industry requires efficient management systems. COSMO Process Manufacturing helps with challenges in production, such as batch production and capacity planning. The solution shows comprehensive information at a glance, for better decisions and a significant reduction in set-up time.

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Life Sciences

As a life science company, you are confronted with heavy regulation. For your team, this means extensive verification and documentation requirements. Digital transformation helps you to reduce this workload. This frees you up to bring innovative products to market faster.

Digitizing MedTech: Compliance, efficiency, and innovation with Microsoft solutions

AI in medical technology: From analysis to process optimization

Risk management and compliance in medical technology

6x Microsoft Solutions Partner

Microsoft Dynamics Inner Circle

Top employer

Are MDR compliance, ISO 13485, and UDI supported?

How do COSMO CONSULT medical technology solutions specifically reduce our validation efforts (CSA/GAMP 5)?

Can existing systems or databases be connected (PLM/PDM, DMS, NiceLabel, EUDAMED/GUDID, EDI)?

How do COSMO CONSULT medical technology solutions ensure data protection and data security ( , Cloud, 21 CFR Part 11)?

What are the advantages of integrated quality management (CAPA, deviations, approvals, document control)?

How does COSMO CONSULT support AI-assisted analyses for quality and planning?

What options are available for training, support, and change management—and also for high user acceptance?

What cost models are possible (cloud operation, terms, scaling)?

Does the solution support complex manufacturing processes and mixed manufacturing methods?