QUALITY STANDARDS

The development and manufacturing in IVD faces challenges resulting from:

●  The need to bring new concepts to market at an ever faster pace.

●  Pressure to deliver products in the most cost effective manner possible.

●  Increasing customer expectations for superior quality.

●  Globalization of operations and supply chains.

These challanges support the need for a high level quality management. G-Bio uses ISO 13485 and integrates this Quality Management System and Design Control Standard within every assay development and manufacturing project.

G-Bio is experienced in all phases of assay development and makes sure that every new product meets the highest performance standards.

G-Bio offers small to medium scale pilot and commercial production capabilities through trusted partners who are ISO 13485 certified.