Medical devices standard 13485 coming soon!
22 August 2022
With growing customer demand in the medical device sector, Tex Plastics have been working towards the quality standard 13485 and expect to have full accreditation before the end of 2022.
Helping medical device manufacturers develop plastic housings
Tex Plastics Barnstaple has developed a successful track record for helping medical device manufacturers develop plastic housings for their prototype product casings. Offering a comprehensive ‘concept to completion’ project solution, which utilises white room and clean room plastic injection moulding. The business has carved out a reputation for helping medical device manufacturers develop concept projects through the prototype stages into low volume production runs and beyond.
A key area for growth
Medical products were recognised as a key area for growth for the Barnstaple facility resulting in investment of the Class 7 Clean Room. This enabled us to secure further new business enabling us to invest in a second Class 7 plastic injection moulding facility. Our 'Design for Manufacture' approach, where our technical team works with the medical device product design team, means we take the ‘proof of concept’ prototypes to create a manufacturing plan.
Medical devices standard 13485
ISO 13485 is the medical industry's optimal medical device standard, which ensures that all medical devices meet the proper regulatory compliance laws and customer needs. Manufacturing bespoke high-quality medical device plastic components which are accredited to ISO 13485, will open up even more doors in the sector.