Graphenea has obtained ISO 13485 certification for manufacturing medical device components. The certification relates to the GFET product line and the Graphene Foundry service.
The ISO standard is an important certification needed for the commercialization of medical applications of graphene, in particular non-implantable biosensors. Graphenea obtained certification for the entire process chain, including raw materials, design, development, manufacture and sale. The certificate also applies to facilities, quality management, tracing, and data analysis. The ISO certificate was issued after an independent audit by SGS.
The certificate is an important technology and business development step for propelling the commercial applications of our GFETs along the full value chain. The certificate, which has been obtained for “design, development, manufacture and sale of biosensors based on graphene technology as a component for a non-implantable active diagnostic device”, is a significant leverage for supporting our customers that are developing diagnostic and medical device applications. The audit was performed for the GFET S2X range of devices and the process flow used to make those devices, which translates to a validation of the Graphene Foundry service for medical device manufacturing.