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Quality assurance and regulatory affairs

Medical Development Experts

Our product development experts partner with innovators and established medical device companies to design, develop, and industrialise single-use medical devices that meet the highest technical, manufacturing, and regulatory requirements.

MULTI-APPLICATION EXPERTISE

With extensive experience across a wide range of healthcare applications — from specialised complex niche devices to high-volume single-use products—Promepla provides a strong foundation for every new project.

Turning concepts into manufacturable medical devices

Product Design & Development

Product Design & Development

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ISO 8 clean rooms

3500m²

dedicated professionals

450

injection moulding machines

27

extrusion lines

7

Our services include

  • Product development: programme costing, fit-for-purpose analysis, material selection, DFMEA risk analysis, design for manufacture.

  • Tool, component, and device design

  • CAD modelling

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