Performance

Because performance is measured against what the manufacturer states, the claims in the labeling and technical documentation set the standard the device is judged by. Vague claims make performance hard to demonstrate and hard to defend in vigilance.

‘performance’ means the ability of a device to achieve its intended purpose as stated by the manufacturer;

EU MDR, Article 2(22)

measurable result Note 1 to entry: Performance can relate either to quantitative or qualitative findings. Note 2 to entry: Performance can relate to the management of activities, processes (3.24), products, services, systems or organizations. [SOURCE: ISO 9000:2015, 3.7.8, modified — Note 3 to entry has been deleted]

ISO 19011:2018, clause 3.25