Clinical Evaluation of Software as a Medical Device
$149.00
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The clinical evaluation of software as a medical device procedure governs the clinical evaluation activities, including assessment and analysis of the clinical safety, effectiveness, and performance, of software as a medical device product. Clinical evaluation is a systematic and planned process to continuously generate, collect, analyze, and assess the clinical data pertaining to a SaMD product and to generate evidence verifying clinical performance. The clinical evaluation of software as a medical device procedure is ISO 13485, MDR 2017/745 and FDA QSR compliant. The content is written in MS Word format and can be easily modified to suit your needs.
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