Quality registration covers medical device design

Triteq has achieved the challenging ISO13485 quality registration for medical device design.

Triteq has achieved the challenging ISO13485 quality registration for medical device design.

Triteq is the only design subcontractor in the UK to be certified to this standard by TUV and one of only a few design houses in the UK to hold ISO13485 quality management approval.

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.

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