Triteq Service Description
Triteq is a product design and development consultancy specialising in the support of medical device development including regulatory consultancy. We have experienced teams of industrial designers and human factors consultants, electronics and embedded software engineers, and app developers as well as prototyping and small-scale production all on site at our main office in the M4 corridor. The teams and project work incorporate our regulatory experience in taking products from initial concept all the way through to CE marking and FDA approval. We work with a range of customers from entrepreneurs, start-ups and spin outs from the universities, in particular working closely with the University of Oxford and Oxford Innovation, and established multi-national and global organisations. Our BS EN ISO 13485 accreditation covers the design and development of medical devices and associated software and production of medical devices, and the team work closely to the following standards on a day to day basis:
- BS EN 62304 Medical device software – software life-cycle processes,
- BS EN 62366 Medical devices - application of usability engineering to medical devices
- BS EN ISO 14971 Medical devices - application of risk management to medical devices
- IEC 60601 General requirements for basic safety and essential performance for medical electrical equipment.
Our past projects include the development of diagnostic equipment, drug delivery devices and tele-medicine applications as well as energy, transport, environmental and other sectors.
We provide support for concept ideation and product design to manufacture for organisations with ideas for new products. We work to a process which meets the necessary regulatory requirements for medical and non-medical products and will undertake formal verification and support during external testing for successful CE marking and other regulatory approval. Within our production capabilities we can produce rapid prototyping using our 3D print facilities and also offer bespoke hardware assembly, including electronics, cable assemblies and enclosures and PCB manufacture.
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