FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to medical device reporting. The document...
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published a guidance document dedicated to design control. The scope of the document covers such aspects as design input and design output. The...
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published a guidance document dedicated to labeling requirements. The aspects covered by the scope of the guidance include labeling requirements for...
EU MDR/IVDR
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission composed of representatives of all the EU Member States, issued guidance dedicated to the Unique Device Identification (UDI) system implemented by the Medical Device Regulation...
Uncategorized
The Malaysian Medical Device Authority (MDA) issued official guidance dedicated to notification for orphaned medical devices. Scope of the Guidance The document was published by the MDA in order to assist all parties involved in operations with medical devices to...
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