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With a sound understanding of medical standards and their interpretation by BSI and TUV, Triteq has change control procedures and source traceability, which is suitable for FCC approval.

Its structured in-house procedure for developing medical products includes the risk analysis, verification, validation and design documentation that you would expect for such a sensitive product market.

Triteq is registered by TUV Munich to ISO13485-2003 for medical device design and development. Using its knowledge and experience, Triteq can bring a product from concept to approval and then to market in an exceptionally short period of time.

Triteq has specific experience in the following areas of safety critical design:

• Wound management systems.
• Development of revolutionary ambulatory and volumetric pumps.
• Cancer detection.
• Foetal blood analysis and syringe driver technology.