GEO IS INTERNATIONALLY CERTIFIED
ISO standards are voluntary. ISO is a non-governmental organization and it has no power to enforce the implementation of the standards it develops. A number of ISO standards - mainly those concerned with health, safety or the environment - have been adopted in some countries as part of their regulatory framework, or are referred to in legislation for which they serve as the technical basis. Although voluntary, ISO standards may become a market requirement.
ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
CE marking is a mandatory conformance mark on many products placed on the market in the European Economic Area (EEA). With the CE marking on a product the manufacturer ensures that the product is in conformity with the essential requirements of the applicable EC directives. The letters "CE" stand for "Conformité Européenne" ("European Conformity").