The Center for Devices and Radiological Health (CDRH) is the branch of the FDA responsible for the premarket approval of
CE marking is a certification mark that indicates conformity with health, safety, and environmental protection standards for products sold within
The Food and Drug Administration (FDA or USFDA) is a federal agency of the United States Department of Health and
FDA approved requests are for items that are new or substantially different and need to demonstrate “safety and efficacy”.
FDA clearance requests are for medical devices that prove they are “substantially equivalent” to the predicate devices already on the
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A notified body is an entity that has been accredited in the European Union by a Member State to assess
These are 2 examples. For more see to our Glossary!