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Medical Device case studies - UK manufacturing - UK moulders

Generation of Technical Files

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Link to Tivatek.com

The Challenge:


A UK company developed a range of TIVA (Totally intraveneaous anaesthesia)  kits designed to suit a wide variety of surgical procedures including ICU applications and day case surgery.

This company searched for a manufacturer with the ability to manage the complex process of writing the technical files for each TIVA kit. They also needed a partner to develop the  injection moulding and assembly process from concept to completion – as well as all packaging, sterilisation and distribution services - leaving them to concentrate on getting their innovative product to market.TIVA Kit

Key capabilities:

  • Complete project management
  • Component outsourcing
  • Sterilisation services
  • Generation of technical files


Complex assembly:
Solvent bonding
UV bonding

 

The Solution

Working from initial drawings Europlaz was able to manufacture samples and generate technical files for each kit, in a process of getting approval for the range from our accrediting body – SGS. All components, including a high-flow distal valve and migration proof end caps have been outsourced by Europlaz and incorporated into a simple unit price.


Once packaged and labelled all kits are ETO sterilised and stored by Europlaz ready for delivery to the end user.