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How To Approach Biological Equivalence Under The EU MDR

Under the EU MDR, an equivalence strategy can save you time and resources, as clinical data from an equivalent device can be used to demonstrate the.

Jaishankar kuttyInternational organization for standardizationDevice coordination groupDevice regulationMedical device directiveSubject device usesDifferent type of the sameClinical evaluation

RQM+ Shares Free Search And Filter Tool For The EU Medical Device Regulation

Most regulatory and quality professionals can think of a time when they struggled to find a specific requirement in the EU Medical Device Regulation.

Nancy morrisonJaishankar kuttyClinical servicesRegulatory quality consulting servicesDevice regulationVitro diagnostic regulationVice presidentNotified bodiesExecutive directorQuality consulting services

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