Triteq gets ISO13485 Registration for Medical Device Design

Triteq Limited is a UK-based technology solutions provider specialising in electronic design and production services for both consumer and business clients. Triteq serves a broad market base of customers with a focus on telematics and safety-critical electronics and provides them with high quality, pioneering design solutions tailored to meet their precise requirements. These include electronic and electromechanical design, software, control platforms and integration of telematics technologies. Customers within medical, telecoms, exploration and product innovation sectors benefit from Triteq’s in-house operations; comprising design, production, test, tooling and medical clean room facilities.



The TUV/ISO13485 registration is considered the most comprehensive of the existing medical industry standards according to Ken Hall, Technical Director at Triteq, “This registration is the culmination of 9 months of rigorous work by the design team to document and formalise our processes for medical device designs.” Jackie Berry, Managing Director at Triteq added, “The medical device industry is an integral part of our business so with this standard applied to our design processes Triteq’s customers can benefit from a smoother approvals process and time to market.”



ISO13485 is the Quality Management Standard harmonised with the Medical Directive and as such documents in full the design processes and structure of the registered company. This means that companies subcontracting to a registered design house do not have to perform that part of the approvals process themselves, enabling them to shorten their route to Medical Device Directive/ CE marking.



With over 50 years’ experience, TUV Product Service is a leading international expert providing testing, certification/qualification and consultancy services to a range of industry sectors covering defence, aerospace, transportation, radio and telecommunications, industrial, IT/Consumer and medical to name but a few. A UKAS accredited testing laboratory (no. 0141) with a proven multi-disciplinary team, TUV Product Service is capable of handling the most demanding projects to the strictest timescales.