Medical Device Moulder

Specialists in the development and manufacture of medical devices, components and packaging. With extensive Class 7 Cleanroom manufacturing cell capability for injection moulding and component assembly of non-sterile medical products.

 



Committed to supporting our customers

  • ISO 13485 Medical Devices accreditation
  • Fully validated EN14644 class 7 (10,000) cleanrooms
  • Concept to completion project solution
  • Working to BS13485 class 7 (10,000)
  • Moulding and assembly
  • Up to 300 tonne clamp force

TEX PLASTICS have carved out a niche for producing plastic injection moulded housings and parts for medical device usability testing and clinical trials. With a growing reputation for helping medical device manufacturers develop concept projects through the prototype stages into low volume production runs and beyond.

TEX PLASTICS operate a UKAS ISO 13485 (Medical Devices) management system, assessed and registered by NQA. This enables TEX PLASTICS to consistently meet customer and applicable regulatory requirements when developing plastic injection moulding and assembly solutions for medical device manufacturers.

  • Plastic injection moulding for usability testing and clinical trials
  • Disposables and Surgical Instruments
  • Implants, Orthopaedic Devices and Ophthalmic Devices
  • Diagnostic and Patient Monitoring Components
  • Medicine Delivery Systems and Medical Packaging

Get a quick quote for your project or advice on how to get a product made in plastic.

 

 
EN14644 class 7 (10,000) cleanroom

EN14644 class 7 (10,000) cleanroom

Tex Plastics has a Class 7 Clean Room manufacturing cell for injection moulding and component assembly of non-sterile medical products. Offering a comprehensive ‘concept to completion’ project solution, which utilises white room and clean room plastic injection moulding.

Class 7 Clean Room Injection Moulding

Concept to completion project solution

Concept to completion project solution

Tex Plastics Barnstaple facility has a long and highly credible history in moulding for the medical sector. With extensive white room moulding and a fully validated EN14644 class 7 (10,000) expanded clean room manufacturing cell – we’ve developed a niche in the lower volume, concept to production, medical device plastic moulding. Our proven process helps medical device manufacturers map their critical path for the Alpha and Beta prototype stages.


ISO 13485 Medical Devices

ISO 13485 Medical Devices

TEX PLASTICS maintains ISO 13485, the medical device industry’s most widely used international standard for quality management. This is the medical industry’s optimal medical device standard, which ensures that all medical devices meet the proper regulatory compliance laws and customer needs.


Ophthalmic medical devices 60% reduction in cost to produce

Ophthalmic medical devices 60% reduction in cost to produce

Understanding the importance of comfort influenced the moulding and fixing techniques to contribute to the ground breaking device for vitreo-retinal specialists and ophthalmologists.
With a redesign of tooling and the change of polymer, it enabled ultra thin moulding to hit the clients usability requirements. Consolidation of parts into a single assembly also shortened lead-times, so even with Intensive testing and product validation, the clients supply chain shortened – further reducing the plastic component manufacturing costs.


Improves usability and reduces costs medical polyware

Improves usability and reduces costs medical polyware

In the high pressure environment of an operating theatre, seconds count. Whether rapid response to saving lives or maximising the efficiency of a theatre or treatment room.
With a redesign of tooling and the change of polymer, it enabled ultra thin moulding to hit the clients usability requirements. Because the ultra-thin moulding resulted in lighter products, packaging costs were reduced. Most important of all, the products usability – in other words the product performance – was significantly improved.


Scope Sterilising Container reduces costs of a large DIN tray by 66%

Scope Sterilising Container reduces costs of a large DIN tray by 66%

Tex Plastics were able to help the designers enhance the manufactured product so it could meet the extremely demanding environmental and usage requirements. The design process involved several innovations; from Silicone grips to ensure delicate scope and instruments doesn’t get damaged during the cleaning and sterilising process; to smooth corners preventing damage to wrapping papers.