Vivacta has a validated product development and manufacturing process with a certified quality system. Its in-house pilot facility provides Vivacta and its partners with development-scale cartridge manufacturing capability.

Vivacta achieved ISO13485 compliance in early 2009.

Vivacta’s cartridge comprises only 8 components and includes no liquid reagents.

It is designed for low cost, high volume manufacture in a 7 stage transferable process involving fabrication of the sensor (manufacture of the PVDF film followed by lamination), application of chemicals (parylene coating, protein surface preparation and reagent deposition), assembly and packaging.