clinical performance means the ability of a device to yield results that are correlated with a particular clinical condition or a physiological or pathological process or state in accordance with the target population and intended user;
clinical performance means the ability of a device, resulting from any direct or indirect medical effects which stem from its technical or functional characteristics, including diagnostic characteristics, to achieve its intended purpose as claimed by the manufacturer, thereby leading to a clinical benefit for patients, when used as intended by the manufacturer;
clinical performance means the ability of a device to achieve its intended purpose as claimed by the manufacturer, including any direct or indirect medical effects on humans as well as the clinical benefit on patients resulting from the technical or functional, including diagnostic characteristics of a device, when used as intended by the manufacturer;
More Definitions of clinical performance
clinical performance means the ability of a device to yield results that are correlated with a particular clinical condition or a physiological state in accordance with the target population and intended user;
clinical performance. The ability of a medical device to achieve its intended purpose as claimed by the product owner.
clinical performance means any direct or indirect medical effects on humans as well as the clinical benefit on patients resulting from the technical or functional, including diagnostic characteristics of a device, when used as intended by the manufacturer; 35’
clinical performance means the ability of a device, resulting from any direct or indirect medical effects which stem from its technical or functional characteristics, including diagnostic
clinical performance means the ability of a device, resulting from any direct or indirect medical effects which stem from its technical or functional characteristics, including diagnostic characteristics, to achieve its intended purpose as claimed by the manufacturer, thereby leading to a clinical benefit for patients, when used as intended by the manufacturer; ee) Klinik performans: İmalatçının belirlediği amaç kapsamında kullanıldığında cihazın, imalatçı tarafından beyan edilen kullanım amacını yerine getirmek ve bu suretle hastalar üzerinde klinik fayda sağlamak üzere diyagnostik karakteristikleri de dâhil olmak üzere, teknik veya işlevsel karakteristiklerinden ortaya çıkan doğrudan veya dolaylı herhangi bir tıbbi etkiyle sonuçlanan kabiliyetini,
clinical performance means the clinical validity, and if appropriate, the clinical utility of the device in relation to its intended purpose;