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Quality assurance and regulatory affairs

Advanced Prototyping

Promepla ​leverages state-of-the-art design software and integrated manufacturing ​capabilities to ​produce high-quality prototypes ​efficiently, helping customers accelerate product development and ​industrialisation.

EFFICIENT BY DESIGN

Our experts continuously ​optimise product design and ​material selection to improve manufacturability, reduce ​development time, and ensure ​a robust, scalable manufacturing process.

Efficient prototyping and comprehensive testing to accelerate validation

Prototyping & Testing

Prototyping & Testing

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ISO 8 clean rooms

3500m²

dedicated professionals

450

injection moulding machines

27

extrusion lines

7

Our services include

  • Polymer selection and material recommendations

  • Rapid prototype model manufacture

  • Prototype mould design (aluminium or steel)

  • Design assessment and tool improvement      recommendations

We also ​provide comprehensive validation and qualification services to ensure your medical devices meet the highest regulatory, functional, and safety ​requirements. From design verification and validation to process qualification and validation, ​Promepla ensures that ​every stage of your project is fully controlled​, documented, and compliant.

Testing services include

  • Master validation plans and protocols

  • Process validation

  • Design of experiments (DOE)

  • Installation qualification (IQ)

  • Operational qualification (OQ)

  • Performance qualification (PQ)

  • Measurement system analysis (MSA)

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