EN iSO 13485 MEDDEV 2.7.1

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Let Us Help You Comply With MEDDEV 2.7/1 rev 4

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How do we determine what is considered current “state of the art”? How much additional preclinical or nonclinical data will be needed?Īre our technical literature reviews adequate? How does MEDDEV 2.7/1 rev 4 differ from previous requirements? Do we have adequate clinical data to meet EU MDR requirements?

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