On Target for ISO 13485
10 October 2022
With our gap analysis and process implementation complete, we're on target for full ISO 13485 accreditation in December this year!
Specialist medical device moulder
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.
Usability testing and clinical trials
Whether working on prototype development stages and managing expectations, usability testing and clinical trials or simply providing an efficient injection moulding solution - our medical device client base has grown organically. This growth has led to us seeking ISO 13485 accreditation, this has enabled us to further support this growing sector.
Understanding the medical device market
Helping develop and produce solutions for a rapidly changing global healthcare market requires innovative thinking and a collaborative approach. Working with the medical device manufacturers we’ve learnt that the aesthetics of the device are often as important as the solution it delivers. Whether the client needs us to create a bacteria resistant surface, a comfortable grip for prolonged use or some other device specification.
Tex Plastics have flexible scale up production for cost efficiency
The objective when working on any medical prototype and product development project is to set clear expectations for the development team, management team and investors – as this will keep everyone pulling in the same direction during product development. Having a critical path where the manufacturing process is being fully considered through the pilot programme stages, has proved a highly successful approach for Tex Plastics and their respective medical device clients.