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Glossary

GMDN – Global Medical Device Nomenclature.

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GMDN is a comprehensive set of terms that provides generic descriptors for the identification of all medical device products, comprised of a Term Name, a (numerical) Code and a Definition. GMDN is used for: 

  • Data exchange between healthcare stakeholders including manufacturers and regulators 
  • Post-market Device safety 
  • Supply chain organisation. 

Other glossary definitions

S

Signal

Information arising from one or multiple sources, including observations and experiments, which suggests a new…

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P

Pre-Sub Meeting

FDA Pre-Sub meetings are available for manufacturers to obtain regulatory feedback on various medical device…

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