Medical devices in the nomenclature of pharmaceutical manufacturers

PROGRAM Devices at the border of definitions: medical devices supplied with the medicinal product; medical devices as a means of drug delivery; devices, an integral part of which is a medicinal product; devices for IVD, RUO (research use only) and general laboratory equipment. Conformity assessment through self-declaration. Conformity assessment performed by conformity assessment body: choosing […]

Development and implementation of a quality management system ISO 9001

Conformity assessment for I class medical devices and some devices for IVD. Technical file structure.