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Cegeka & Microsoft Dynamics 365

ERP for MedTech & Medical Device Companies

Accelerate innovation, ensure compliance, and scale globally with an ERP solution built for regulated MedTech environments.

Supporting:
Medical Technology • Medical Device • IVD • Digital Health • SaMD companies

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Challenges

Common ERP Challenges for MedTech companies in Sweden

MedTech companies in Sweden operate in one of the most regulated and innovation-driven industries in the world.

From MDR and FDA requirements to increasing demands for traceability, quality, and global scalability, traditional systems are no longer sufficient.

You need a platform that connects your entire organization from product development to post-market surveillance while ensuring compliance at every step.

What we do

A modern ERP platform for MedTech

Microsoft Dynamics 365, combined with Cegeka’s industry solution, provides a flexible, cloud-based ERP platform tailored for Medical Technology companies.

It enables:

Real-time visibility across R&D, quality, manufacturing, and supply chain
Seamless scaling from early-stage innovation to global commercialization
Integration with data, AI, and connected device ecosystems
Secure, validated environments for regulated operations

ERP in MedTech

Business outcomes for MedTech companies

Faster time-to-market for medical devices and innovations
Reduced compliance risk (MDR, FDA, ISO 13485)
Full device traceability and audit readiness
Scalable operations across global markets

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Regulatory Compliance

Stay fully compliant with MDR, FDA 21 CFR Part 11, and ISO 13485 through built-in audit trails, controlled documentation, and electronic signatures embedded directly into your daily operations.

End-to-End Device Traceability

Achieve complete visibility across the product lifecycle with UDI, batch and serial tracking, and full product genealogy, ensuring traceability from suppliers to patients.

Integrated Quality Management

Manage quality processes directly within ERP, including CAPA, deviations, and approvals, while maintaining complete audit documentation and control across all operations.

Connected Product Lifecycle

Connect design, manufacturing, distribution, and post-market surveillance in one system, enabling seamless control and compliance throughout the entire device lifecycle.

Digital Health & MedTech Innovation

Support modern MedTech innovation with integration for connected devices, SaMD, and advanced data platforms, enabling real-time insights, analytics, and AI-driven optimization.

Scalable & Cloud-Based Operations

Scale your MedTech business seamlessly with a secure, cloud-based ERP platform that supports global expansion, multi-site operations, and real-time data access, without compromising compliance or performance.

Core Capabilities for MedTech (Medical Technology)

Built on Microsoft Dynamics 365

Your ERP platform is powered by Microsoft technology, providing:

Cloud-based, scalable architecture
Seamless integration with Azure, Power BI, and Teams
Continuous innovation through AI and automation
Enterprise-grade security and compliance
Cegeka industry-tailored ERP solution

This is more than an ERP system - it’s your digital backbone.

Who It’s For

Who This ERP Solution Is For

This solution is designed for:

MedTech companies scaling from research to commercialization
MedTech and Medical Devices organizations replacing legacy ERP systems
MedTech manufacturing companies operating in regulated environments
Companies needing validated ERP systems and compliance support

If you're evaluating:

ERP for MedTech companies
A validated ERP system

Cegeka can help you find the right fit.

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From Strategy to Go-Live and Beyond

We combine industry expertise with a structured delivery approach:

01 Assessment & Strategy

Define your business needs and compliance requirements in detail, from core processes, reporting, and integration expectations to sector-specific regulations, data protection rules, and audit obligations so your ERP solution supports daily operations, reduces risk, and is ready for future regulatory change.

02 Solution Design

Design an ERP architecture that fits your unique processes today and scales with your growth tomorrow, from finance and operations to supply chain and customer service so your systems support your strategy instead of limiting it.

03 Implementation & Validation

Design your cloud strategy and plot your roadmap to the cloud to ensure a smooth shift tailored to your needs - at your own pace.

04 Go-Live & Optimization

Ensure adoption, stability, and continuous improvement by guiding your teams through structured change management, providing targeted training and support, monitoring system performance and user feedback. Keep your ERP landscape secure, up to date, and fine-tuned to new business needs, so it continues to deliver measurable value long after go-live.

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Why Cegeka

Why Choose Cegeka?

Cegeka combines deep MedTech expertise with Microsoft Dynamics 365 to deliver compliant, traceable, and future-ready ERP solutions designed for audit readiness, faster implementation, and long-term innovation.

About Cegeka

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What You Achieve

With the right ERP solution in place, you can:

Reduce compliance risk
Improve operational efficiency
Increase visibility across your organization
Accelerate time-to-market
Scale with confidence

Awards and Certifications

Recognized for innovation and delivery excellence

Recognized by industry leaders and trusted by Microsoft, Cegeka combines validated methodologies, top-tier partner status, and award-winning expertise to deliver compliant, scalable, and future-ready ERP solutions.

Our recognition includes distinctions such as Microsoft Inner Circle membership, Partner of the Year awards, Microsoft Frontier Partner status, and validation by Epista for Life Sciences, demonstrating our ability to meet the highest standards in both innovation and regulatory compliance for companies operating in complex, regulated industries.

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Start Your ERP Journey Today

Whether you're scaling your MedTech company or modernizing your ERP landscape, we’re ready to help..

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FAQ

ERP for Medical Technology companies

An ERP system for MedTech is an integrated platform that connects R&D, clinical, manufacturing, quality, and supply chain processes in one system. It enables full lifecycle management, from research to commercialization, while ensuring compliance with strict regulations such as GxP, FDA, and EMA.

Why do biotech and life sciences companies need a specialized ERP?

Generic ERP systems lack the built-in compliance and traceability required in regulated environments. A MedTech ERP is designed to handle:

GxP-regulated processes
Batch and lot traceability
Quality and validation workflows
Regulatory documentation

This ensures compliance, reduces risk, and supports scaling from clinical phase to commercial manufacturing.

How does ERP support MedTech compliance?

By embedding MDR, FDA, and ISO 13485 requirements into daily operations through audit trails, documentation control, and automated workflows.

More insights

What is batch traceability and why is it critical in MedTech?

UDI traceability ensures each medical device can be tracked throughout its lifecycle, improving compliance, recall management, and patient safety.

A modern ERP provides end-to-end visibility across the entire supply chain.

More insights

How does ERP help with validation and audit readiness?

ERP systems designed for life sciences follow structured validation methodologies (e.g., GAMP 5), ensuring that systems are validated and documented from day one.
This enables:

Faster validation processes
Reduced compliance risk
Always up-to-date audit documentation
Continuous inspection readiness

How does ERP support MedTech companies scaling from R&D to commercial production?

ERP enables MedTech companies to transition from flexible R&D environments to controlled, compliant manufacturing by standardizing processes, integrating quality management, and ensuring full traceability—allowing them to scale efficiently while meeting MDR, FDA, and ISO 13485 requirements.

How does Microsoft Dynamics 365 support life sciences ERP?

Microsoft Dynamics 365 provides a scalable, cloud-based ERP platform that connects R&D, quality, manufacturing, and supply chain in one system—enabling real-time visibility, built-in compliance, and data-driven decision-making for MedTech companies.

What makes Cegeka’s ERP solution unique for MedTech industri?

Cegeka’s ERP solution stands out by combining the flexibility of Microsoft Dynamics 365 with a validated, industry-specific framework designed for MedTech and medical device companies.

Unlike generic ERP systems, it embeds regulatory compliance (MDR, FDA, ISO 13485), end-to-end traceability, and integrated quality management directly into core business processes. This ensures that compliance is not an add-on—but a natural part of how the business operates.

Can ERP improve quality and manufacturing in MedTech?

Yes. ERP systems enhance quality and manufacturing by:

Integrating quality management into production
Automating batch control and deviations
Ensuring adherence to GMP standards
Providing real-time insights into production performance

This leads to consistent product quality and reduced compliance risk.

Is cloud ERP secure and compliant enough for Medical Technology manufacturing organisations?

Modern cloud ERP solutions meet strict security and regulatory standards, offering:

Data encryption and access control
Validated environments
Continuous updates and compliance support
High availability and disaster recovery

This makes cloud ERP a strong foundation for compliant and scalable medtech operations.

More insights

Can ERP handle both manufacturing and quality?

Yes, ERP integrates manufacturing and QMS processes in one platform, ensuring consistent quality and compliance.

We believe in shaping digital together. We don’t just deliver technology, we work shoulder to shoulder with our clients to ensure technology drives impact when and where it matters most.

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ERP for MedTech & Medical Device Companies

Common ERP Challenges for MedTech companies in Sweden

A modern ERP platform for MedTech