Portfolio – 1 Column

ISO13485:2016

An international standard that specifies requirements for a quality management system specific to the medical device industry.

Food and Drug Administration

The FDA (Food and Drug Administration) is a U.S. government agency responsible for regulating and supervising the safety of foods, drugs, medical devices, and other consumer products. You can click to jump link and search “OURPROMISE” on the official website.

Conformité Européenne

The CE marking is a certification mark that indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area.