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our Framework

THE INDUSTRIALISATION PLATFORM

A structured pathway to successful industrialisation - built around control, predictability, and reduced risk at every phase.

Aligned with APQP principles and designed to connect every stage of your product journey.

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The pathway to success

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Stage #1

DEFINE & DE-RISK

Establish strategic clarity, regulatory pathways, and manufacturing feasibility before committing capital.

Risk assessment, requirements capture, and feasibility studies aligned with APQP Phase 1 principles.

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Stage #2

DESIGN & VALIDATE

Develop, verify, and validate your device with manufacturability and compliance engineered from the start.

DFM/DFA, V&V planning, root cause analysis, and structured problem solving built into every design decision.

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Stage #3

INDUSTRIALISE

Bridge the gap between development and production with rigorous process validation and supplier qualification.

IQ/OQ/PQ validation, manufacturing process design, pilot builds, and right-sized production system setup.

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Stage #4

MANUFACTURE

Deliver controlled, repeatable production with full traceability and quality assurance at every step.

Cleanroom assembly, electromechanical integration, batch and serialised production with complete DHR.

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Stage #5

SCALE & OPTIMISE

Continuously improve cost, quality, and supply chain performance as production volumes grow.

VAVE programmes, yield improvement, capacity planning, and operational excellence initiatives.

Core Positioning

Defining Predictable timelines

Structured industrialisation frameworks deliver predictable timelines from pilot to full-scale production — eliminating delays and controlling milestones at every stage.

→ Faster time to market with controlled milestones

  • Phase-gated milestone frameworks aligned with APQP

  • Clear deliverables at each industrialisation stage

  • Risk-based scheduling with contingency planning

  • Real-time programme visibility and reporting

Developing cohesive supply chains

A single integrated platform - from engineering through manufacturing - eliminates handoff gaps, maintains full traceability, and ensures complete accountability.

→ One platform, complete accountability

  • End-to-end supply chain design and qualification 

  • Strategic sourcing with dual-source strategies 

  • Supplier performance monitoring and development

  • Full material traceability from raw to finished goods

RIGHT-SIZING MANUFACTURING

Flexible manufacturing solutions that scale with your product lifecycle - from initial production runs through commercial volumes — ensuring the optimum delivery at every stage.

→ Manufacturing that fits your stage and scales with your growth

  • Clinical investigation and pilot production capabilities

  • Modular manufacturing cells for volume flexibility

  • Cleanroom and controlled environment production

  • Capacity planning and automation roadmaps

CLOSING THE INDUSTRIALISATION GAP

Bridging development and production with rigorous process validation, root cause analysis, and structured problem solving.

→ Engineering and manufacturing aligned from day one

  • DFM/DFA integrated into design reviews

  • IQ/OQ/PQ process validation frameworks

  • Root cause analysis and CAPA systems.

  • Continuous improvement is embedded in operations.

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Our Mission

The medical device industry is one of the world’s most innovative and dynamic sectors — driven by breakthrough technologies that have the potential to transform patient care globally.

 

However, turning innovation into widespread clinical impact requires more than a great idea. Success depends on the ability to industrialise, scale, and manufacture products reliably to the highest global healthcare standards.

 

We recognised a major opportunity: bringing together clinical expertise, engineering excellence, and world-class manufacturing execution into a more connected and effective model.

 

Our experience has shown that when innovation and operational excellence work seamlessly together, medical technologies can move faster, scale more effectively, and deliver greater impact for healthcare professionals and patients worldwide. We have built an integrated platform that combines clinical insight, manufacturing capability, and engineering excellence to deliver predictable, high-quality, and scalable outcomes for MedTech companies worldwide.

 

CME Devices is more than a manufacturing provider — it is a precision-built operational platform for high-value medical technology, designed to help MedTech innovators scale faster, strengthen quality, and expand global impact.

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