Glossary
Selected key terms pertaining to medical device development are listed below with References.
Key Terms
There are currently 6 key terms in this directory beginning with the letter Q.
qualification
activities undertaken to demonstrate that utilities, equipment, and methods or modes are suitable for their intended use and perform properly
Note: Qualification of equipment and/or processes generally includes installation qualification, operational qualification, and performance qualification.
Note: Qualification of equipment and/or processes generally includes installation qualification, operational qualification, and performance qualification.
[ISO 11139:2018]
qualification
documented process used by the health care product manufacturer to assure the reliability and capability of equipment and/or processes before approval for use in manufacturing
Note: Qualification of equipment and/or processes generally includes installation qualification, operational qualification and performance qualification.
Note: Qualification of equipment and/or processes generally includes installation qualification, operational qualification and performance qualification.
[ISO 13408-1:2015]
quality
the totality of features and characteristics that bear on the ability of a device to satisfy fitness-for-use, including safety and performance
[FDA 21CFR820]
quality
degree to which a set of inherent characteristics of an object fulfils requirements
Note 1: The term “quality” can be used with adjectives such as poor, good or excellent.
Note 2: “Inherent”, as opposed to “assigned”, means existing in the object
Note 1: The term “quality” can be used with adjectives such as poor, good or excellent.
Note 2: “Inherent”, as opposed to “assigned”, means existing in the object
[ISO 9000:2015]
Medical device developers are strongly encouraged to consult the listed reference for each key term to fully understand the context behind the definition and its intended application.
Definitions from the FDA Code of Federal Regulation (CFR) are listed without dates and are accurate through December 2020. Consult the listed FDA reference (online) to confirm the latest definition.