Product Realization

At GXS, ethnography is an integral component of our process and forms a core part of our engineering research function: we value this research of studying the work environment as vital to success for collaboration with surgeons and innovators to embark on bringing differentiated solutions to fruition. 

Medical Device development is an iterative process, and the data gathered from one phase feeds the next or previous phase; therefore, our methods maintain good documentation and control measures to assure capture of all the activities. 

The resultant documentation of design history files (DHF) will identify and describe all parameters that can influence or impact the device design.  As your partner in device development, we follow the design control procedures set by the FDA (21 CFR 820.30) and ISO 13485:2016 standards to properly document all activities accordingly. 

With GXS, Manufacturing Engineering is a core offering that differentiates us from others. Our expertise in Additive Manufacturing, Micro-Fabrication and Molding, and Design for Assembly (DFMA) enables high-quality and economical production of complex medical devices within our organization. 

Having strategic partners in Additive Manufacturing, Molding, and Systems Design we can build, scale, and manage the production in one of our micro-factories or transfer to your facility or contract manufacturer of choice.  We offer comprehensive develop of all tools, processes, machines and equipment; and integrate the facilities and systems for producing quality products with the optimum expenditure of capital.