The US Food and Drug Agency is responsible for both pre and post market regulation of medical devices as well as it’s other responsibilities for Food and Drugs.

Euro-Soft have been commissioned a number of times now both to develop integration and mapping services and to provide consultancy.

Most recently we have developed a user defined polyhierarchical system to allow the appropriate categorisation of medical device terms and a mapping system to allow FDA 510k codes to be mapped directly to the GMDN code and for an output file to be used to help create a new Adverse Incident database to be launched by the FDA next year.