Tex Plastics Newsletter Autumn 2021

Helping you reduce overall production costs Find out how much you could be saving with our FREE Audit Call 01271 378528 Barnstaple or 01332 546773 Derby Technical Moulding, Intelligent Polymer Selection and Lean Supply Chain Solutions Guy Sentance Production Director & General Manager Tex Industrial Plastics Working towards ISO 13485 With the increase in medical device plastic injection moulding, Tex Plastics are now working towards the medical device industry’s most widely used international standard for quality management. Why Tex Plastics is working towards ISO 13485 By adopting this Quality Management System (QMS), will enable us to provide better management support and identify our customer requirements in relation to developing documentation including the Quality Policy, Quality Objectives, and Quality Manual, for the medical device moulding undertaken. This will assist in creating the mandatory and additional processes and procedures necessary, for both organisations to properly create and deliver the new medical device product. The benefits of working towards ISO 13485 Through implementing an ISO 13485 QMS Tex Plastics will facilitate better alignment of design and development requirements to many regulations, plus any requirements for traceability procedures. In addition to managing risk, clarification of management responsibilities and enhancement of product cleanliness requirements in the manufacturing process. Tex Plastics Barnstaple has developed a successful track record for helping medical device manufacturers develop plastic housings for their prototype product casings. Working with designers to develop a DFM product DFM, or Design for Manufacture is where our technical team works with the medical device product design team, taking the ‘proof of concept’ prototypes to create a manufacturing plan. This looks at the projected numbers, cosmetic appearance, plus any specific manufacturing requirements (i.e. white room or clean room manufacture, specialist polymers, 3D printing options, etc.). Our job is to help develop a critical path for the Alpha and Beta prototype stages (typically incorporating 3D printed components) through to the pilot production stage. Tex Plastics can then 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. Justin Davis Managing Director, Tex Plastics Medical prototype and product development Autumn 2021

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