Performance Evaluation Report (PER...by Swapna Makro
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101From IVDR perspective, clinical evidence should support the intended purpose of a device as stated by the manufacturer and that is based on performance evaluation. This...
Deadline Extended for DMF Type III...by Makro Care401
401USFDA Extended the Compliance date for the submission of type III Drug Master Files In eCTD for until May 5, 2020. The DMF Guidance recommends the DMF holders to update...