36 resultaten gevonden voor 'information supplied by the manufacturer'
information supplied by the manufacturer
written, printed or graphic matter affixed to an IVD medical device or any of its containers or wrappers or provided for use with an IVD medical device,
related to identification and use, and giving a technical description, of the IVD medical device, but excluding shipping documents
manufacturer
natural or legal person responsible for the design, manufacture, fabrication, assembly, packaging or labelling of a medical device, for assembling a system, or adapting a medical device before it is placed on the market and/or put into service, regardless of whether these operations are carried out by that person or on their behalf by a third party
information
meaningful data (3.8.1)
by-product
from a process (3.1.5) that is incidental or not intentionally produced and which cannot be avoided
by-product
from a
documented information
information required to be controlled and maintained by an organization (3.1.5) and the medium on which it is contained
documented information
information required to be controlled and maintained by an organization and the medium on which it is contained
information module
compilation of data covering a unit process (3.6.9) or a combination of unit processes that are part of the life cycle (3.6.1) of a product (3.5.12)
documented information
required to be controlled and maintained by an organization (3.2.1) and the medium on which it is contained
quantitative information
that has been processed or analysed to be meaningful for a specific purpose or objective (3.1.6)