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ERP Success Factors for the
Medical Technology Industry

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Discover how MedTech companies in the DACH region tackle regulatory compliance, traceability and supply chain integration. Dreher Consulting helps turn these challenges into measurable results.

Identify Your ERP Success Factors
"Medical technology firms face some of the strictest ERP challenges, where compliance and innovation must go hand in hand." - Dr. Harald Dreher.
Why Dreher Consulting

At Dreher Consulting, we enable MedTech organisations to navigate complex compliance, digital transformation and international growth with independent, vendor-neutral expertise that delivers measurable impact.

We combine regulatory insight with ERP optimisation, AI-driven analysis, and scalable digitalisation to cut risk, streamline processes, and unlock new opportunities. By applying first-principles thinking and a results-first approach, we help MedTech companies turn compliance challenges into competitive advantage.

Analyse Your Growth Pain Points

Why digitalisation is not software. It is the future of your company. image

Why digitalisation is not software. It is the future of your company.
Why independent advice makes the difference and why we deliberately reject up to 30% of inquiries image

Why independent advice makes the difference and why we deliberately reject up to 30% of inquiries
Why the first-principle approach saves ERP and digitalisation projects

Independent consulting: Why the first-principle approach saves ERP and digitalisation projects

Dreher Consulting Addresses Key Issues Across the Medical Industries Value Chain

Medical and life sciences companies face strict regulatory demands, complex supply chains and pressure to innovate at speed. At Dreher Consulting, we align ERP, digitalisation and compliance solutions to help organisations improve traceability, cut costs and ensure patient safety across the entire value chain.

Key Issues
  • Maintaining Traceability Audit Trails
  • End-to-end component traceability
  • Handling temperature-sensitive items efficiently
  • Compliance with MDR, FDA, EUDAMED
  • Real-time inventory management
  • Managing patient-specific prescriptions data
Dreher Solutions
Process Mapping ERP Selection & Implementation: Integrating vendor data within ERP systems to maintain better control over sourcing and procurement.
ERP Implementation (1) Process Optimisation & Management Analyzing and improving supply chain processes to build resilience and flexibility.
It Strategy Consulting ERP Project Management Overseeing ERP projects to support UDI creation, audit trails, and seamless data integration for EUDAMED.
Key Issues
  • Master data for device registration
  • UDI and EUDAMED integration
  • FDA data compliance
  • GDPR compliance
  • Cybersecurity threat protection
  • Seamless data flow across systems
  • Data accuracy and consistency
Dreher Solutions
robot-automation Digital Strategy Consulting: Establishes secure digital frameworks to protect against cyber threats, ensuring data protection and compliance with GDPR and FDA requirements.
Process Optimisation IT Strategy Consulting: Develops a comprehensive data security strategy, identifying vulnerabilities and implementing robust security measures across systems.
ERP Implementation (1) Process Optimisation & Management: Refines data handling processes, strengthening data governance and minimizing security risks by reducing redundancies and potential entry points for breaches.
Key Issues
  • Adhering to GAMP 5 standards
  • Meeting MDR (Medical Device Regulation) requirements
  • Complying with FDA regulations (21 CFR Part 820)
  • Implementing Quality Management & CAPA systems
  • Ensuring CSDR sustainability compliance
  • Maintaining ISO 13485 certification
Dreher Solutions
ERP project management ERP Selection: Ensures ERP systems are configured to meet regulatory requirements, including MDR, FDA, and ISO standards, facilitating efficient compliance management.
Process Optimisation Sustainability Consulting: Integrates compliance with CSDR sustainability requirements, tracking Scope 3 CO2 emissions and aligning them with environmental standards.
ERP Implementation (1) IT Strategy Consulting: Develops a regulatory-compliant digital strategy, ensuring data handling, security, and documentation processes align with standards such as GAMP 5 and GDPR.
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Why Industry
Context Matters

The medical technology sector in the DACH region operates under some of the world’s strictest compliance and quality demands. ERP systems must not only streamline operations but also ensure full alignment with regulatory frameworks, traceability and international collaboration. Dreher Consulting ensures your ERP isn’t just implemented — but tailored to your MedTech compliance and growth needs.

  • Regulatory compliance and traceability — meeting MDR, ISO and CSRD requirements while ensuring patient safety.

  • Complex product lifecycle management — from R&D through multi-country manufacturing and distribution.

  • Global supply chain integration — supporting cross-border operations with accurate forecasting and quality assurance.

Curious which KPIs matter most for your role? Try our Pain Point Analyser
Pain Point Analyser

Key KPIs and Challenges in The MedTech Industry

Medical technology companies in the DACH region face unique pressures — from strict regulatory compliance and clinical traceability to global supply chain complexity. At Dreher Consulting, we help MedTech organisations focus on the KPIs that matter most, turning compliance and operational challenges into measurable improvements.

Feature / Need

Key KPIs (measurable targets)

Typical Challenges (pain points)

Compliance & Regulation
Key KPIs (measurable targets)

100% MDR and ISO 13485 compliance; full CSRD-ready reporting

Typical Challenges (pain points)

Navigating evolving EU regulations while maintaining continuous product innovation

100% MDR and ISO 13485 compliance; full CSRD-ready reporting

Navigating evolving EU regulations while maintaining continuous product innovation

Process Fit
Key KPIs (measurable targets)

25% faster time-to-market for new devices through integrated R&D-to-production workflows

Typical Challenges (pain points)

Aligning R&D, clinical trials, and production in highly regulated environments

25% faster time-to-market for new devices through integrated R&D-to-production workflows

Aligning R&D, clinical trials, and production in highly regulated environments

Scalability
Key KPIs (measurable targets)

30% increase in production efficiency without compromising quality assurance

Typical Challenges (pain points)

Scaling manufacturing while maintaining rigorous testing and traceability standards

30% increase in production efficiency without compromising quality assurance

Scaling manufacturing while maintaining rigorous testing and traceability standards

Localisation
Key KPIs (measurable targets)

Full localisation for DACH and EU-specific medical device regulations and documentation

Typical Challenges (pain points)

Adapting ERP to support multilingual, cross-border compliance and reporting

Full localisation for DACH and EU-specific medical device regulations and documentation

Adapting ERP to support multilingual, cross-border compliance and reporting

Curious which KPIs matter most to your business?
Pain Point Analyser

What requirements do you have to place on ERP consultants?

Advising on the selection of an Enterprise Resource Planning (ERP) system is not easy.

It requires specialised knowledge and a deep understanding to be effective as a consultant in this market segment, where companies need to increase their competitiveness by increasing efficiency or reducing costs, depending on which they choose.

 

Schedule Consultation

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What we do

We develop solutions that shape the future of companies, increasing competitiveness & unleashing potential.

Integral first step:

Process optimisation should be considered before ERP implementation as it ensures the system operates on streamlined, efficient workflows. Without it, ERP systems risk magnifying inefficiencies instead of resolving them. Process optimisation

  • Prevents automating flawed processes
  • Identifies key inefficiencies to address early
  • Aligns system configuration with optimised workflows
  • Maximises ERP’s potential for improved performance
  • Sets the foundation for long-term operational success

Learn More

Future Focused:

Building regulatory compliance capabilities within ERP, especially for sustainability and CSDR, ensures the system is equipped to handle evolving regulations. Early integration minimizes future disruptions and enhances long-term sustainability efforts. The integration of regulatory compliance

  • Embeds compliance tracking into system functions
  • Ensures CSDR capabilities are built-in early
  • Supports automated compliance reporting
  • Reduces future costly system modifications
  • Strengthens sustainability and regulatory alignment from the start

Learn More

A Crucial Foundation:

The selection of an ERP system is fundamental to long-term success. The right system ensures operational efficiency, compliance, and scalability, reduces future costs, and enables sustainable growth. A structured and professional selection process:

  • Aligns system functions with business objectives
  • Reduces future costs for unplanned system changes
  • Supports scalability and future business expansion
  • Ensures the system's adaptability to evolving industry requirements
  • Supports scalability and growth by adapting 
  • Secures stakeholder buy-in

Learn More

Crucial Transformation:

ERP implementation is crucial for transforming business operations by integrating key processes into a unified system. It enhances efficiency, streamlines workflows, and provides real-time data insights, driving overall business success. The implementation of an ERP-system

  • Unifies business functions into a single platform
  • Enhances decision-making with accurate, real-time data
  • Streamlines processes, reducing manual tasks and errors
  • Increases efficiency by automating repetitive operations
  • Supports scalability and growth by adapting to evolving business needs

 

Learn More

Future Foundation:

The AI and Automation module focuses on leveraging technology to improve efficiency, reduce costs, and enhance decision-making. Built on a foundation of standardised processes and clear data, this module helps businesses harness the full potential of AI and automation for sustainable growth. The integration of AI-technologies.

  • Automates repetitive tasks, increasing efficiency
  • Enhances decision-making with data-driven insights
  • Improves productivity by streamlining workflows
  • Scales easily to adapt to growing business needs
  • Personalises customer experiences

Learn More

stack layer one stack layer one Process Optimisation
stack layer two stack layer two Compliance
stack layer three stack layer three ERP Selection
stack layer four stack layer four ERP Implementation
stack layer five stack layer five Automation & AI

Process Optimisation

Integral first step:

Process optimisation should be considered before ERP implementation as it ensures the system operates on streamlined, efficient workflows. Without it, ERP systems risk magnifying inefficiencies instead of resolving them. Process optimisation

  • Prevents automating flawed processes
  • Identifies key inefficiencies to address early
  • Aligns system configuration with optimised workflows
  • Maximises ERP’s potential for improved performance
  • Sets the foundation for long-term operational success

Learn More

Compliance

Future Focused:

Building regulatory compliance capabilities within ERP, especially for sustainability and CSDR, ensures the system is equipped to handle evolving regulations. Early integration minimizes future disruptions and enhances long-term sustainability efforts. The integration of regulatory compliance

  • Embeds compliance tracking into system functions
  • Ensures CSDR capabilities are built-in early
  • Supports automated compliance reporting
  • Reduces future costly system modifications
  • Strengthens sustainability and regulatory alignment from the start

Learn More

ERP Selection

A Crucial Foundation:

The selection of an ERP system is fundamental to long-term success. The right system ensures operational efficiency, compliance, and scalability, reduces future costs, and enables sustainable growth. A structured and professional selection process:

  • Aligns system functions with business objectives
  • Reduces future costs for unplanned system changes
  • Supports scalability and future business expansion
  • Ensures the system's adaptability to evolving industry requirements
  • Supports scalability and growth by adapting 
  • Secures stakeholder buy-in

Learn More

ERP Implementation

Crucial Transformation:

ERP implementation is crucial for transforming business operations by integrating key processes into a unified system. It enhances efficiency, streamlines workflows, and provides real-time data insights, driving overall business success. The implementation of an ERP-system

  • Unifies business functions into a single platform
  • Enhances decision-making with accurate, real-time data
  • Streamlines processes, reducing manual tasks and errors
  • Increases efficiency by automating repetitive operations
  • Supports scalability and growth by adapting to evolving business needs

 

Learn More

Automation & AI

Future Foundation:

The AI and Automation module focuses on leveraging technology to improve efficiency, reduce costs, and enhance decision-making. Built on a foundation of standardised processes and clear data, this module helps businesses harness the full potential of AI and automation for sustainable growth. The integration of AI-technologies.

  • Automates repetitive tasks, increasing efficiency
  • Enhances decision-making with data-driven insights
  • Improves productivity by streamlining workflows
  • Scales easily to adapt to growing business needs
  • Personalises customer experiences

Learn More

Get in Touch

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