![]() M EDDEV 2.7.1 rev.4 is a guidance to manufacturers on how often they should prepare and update the clinical evaluation report and this guidance is also introduce the methodologies, contains additional rules on demonstrating equivalence with other medical devices and to align to the legal requirements. ![]() MDSAP in Chapter 5 : Design and Development, Design Validation.ISO13485 in clause 7.3.7 Design Validation,.The Clinical Evaluation is a part of design validation of QMS standards for Medical Device.Clinical Evaluation is the assessment procedure conducted by device owners to validate whether the intended use, and the user needs for the device which can be achieved based on literatures, clinical evidence and data gathered from the clinical trial.
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