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Medical electronic products require safety critical designs to meet the most stringent standards.

Triteq’s team of design engineers has worked on many medical projects including the development of revolutionary ambulatory and volumetric pumps. Using its knowledge and experience, Triteq can bring a product from concept to approval, allowing the time to market to be reduced to an exceptionally short period of time.

With a sound understanding of medical standards and their interpretation by BSI, TUV, FDA and other international approvals bodies, Triteq has the ability to ‘design for approval’ from the original concept. Triteq has change control procedures and source traceability, which is suitable for FDA approval. Its structured in-house procedures for developing medical products include the risk analysis, verification, validation and design documentation that you would expect for such a sensitive product market.

Triteq’s software design techniques have been developed to use close-coupled two processor systems to guarantee code and hardware fault detection, rectification or failsafe response. The hardware design techniques used guarantee single fault failsafe systems will be designed.

ISO9001 and ISO13485-2003 registration in place.