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7.3.1 Design and development planning: The manufacturer shall establish documented procedu...

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INFORMED CONSENT FORM 1. Checklist for clinical investigation Subject's informed consent ...

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Overall synopsis of the clinical investigation A summary or overview of the clinical inves...

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Design and development planning: The manufacturer shall establish documented procedures fo...

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Metrological traceability of calibrator and control material values Where applicable, summ...

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INFORMED CONSENT FORM 1. Checklist for clinical investigation Subject's informed consent ...

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INFORMED CONSENT FORM 1. Checklist for clinical investigation Subject's informed consent ...

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Overall synopsis of the clinical investigation A summary or overview of the clinical inves...

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Customer communication: The manufacturer shall determine and implement effective arrangeme...

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