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Clinical Evaluation Reports from the medical writer’s ...

14| June 2017 medical Writing | Volume 26 Number 2 Gillian PritchardSylexis Limited, Dundee, Scotland, UKCorrespondence to:Dr Gillian PritchardSylexis Limited30/34 Reform StreetDundee, DD1 1 RJScotland, (0)1382 581545 AbstractClinical Evaluation is a structured ongoingprocedure to collect, appraise and analyseclinical data pertaining to a medical Clinical data include current knowledgeof the condition to be treated, publishedliterature about the target device and anyequivalent devices, information held by themanufacturer about pre- Clinical and clinicalinvestigations, risk management, post-marketsurveillance, and the instructions for use. Theclinical data are analysed for consistencybetween them to identify any gaps oruncertainties that require further Evaluation ,and to show conformity with the EssentialRequirements of the medical DevicesDirective (to be superseded by the MedicalDevices Regulation).

Clinical evaluation is a structured ongoing procedure to collect, appraise and analyse ... Guidance documents used in addition to MEDDEV 2.7/1 include the following: ... Practice and consensus guidelines, health technology assessment reports, systematic review databases e.g. Cochrane, and Competent

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