clinical evidence means clinical data and clinical evaluation results pertaining to a device of a sufficient amount and quality to allow a qualified assessment of whether the device is safe and achieves the intended clinical benefit(s), when used as intended by the manufacturer;
clinical evidence means the information that supports the scientific validity and performance for the use of a device as intended by the manufacturer;
clinical evidence means the same as original clinical evi- dence used in diagnosing a patient's condition or assessing a clinical course and includes, but is not limited to:
More Definitions of clinical evidence
clinical evidence means evidence used in diag- nosing a patient's condition or assessing a clinical course and includes, but is not limited to:
clinical evidence means, in relation to,-
clinical evidence means clinical data and clinical evaluation results pertaining to a device of a sufficient amount and quality to allow a qualified assessment of whether the device is safe and achieves the intended clinical benefit(s), when used as intended by the manufacturer; dd) Klinik kanıt: İmalatçının belirlediği amaç kapsamında kullanıldığında, cihazın güvenliliğine ve amaçlanan klinik faydasına/faydalarına yönelik nitelikli bir değerlendirmeye imkân tanımak üzere cihaza ilişkin yeterli miktarda ve kalitede klinik veriyi ve klinik değerlendirme sonuçlarını,
clinical evidence means the same as original clinical evidence used in diagnosing a patient’s condition or assessing a clinical course and includes, but is not limited to:X-ray films;Digital records;Laboratory slides;Tissue specimens; andMedical photographs.
clinical evidence means the data, positive and negative, supporting the evaluation of the scientific validity and performance for the use of a device as intended by the manufacturer;
clinical evidence means, in relation to,—
clinical evidence means, in relation to -