(b) the intended user (lay person or profession...
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(b) the intended user (lay person or profession...
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3.2 Active medical device—Medical device relyin...
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7.2 Bio-compatibility: (i) The dossier should c...
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Proposed instructions for use or electronic ins...
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The manufacturer shall ensure that changes to d...
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PART IV INFORMATION REQUIRED TO BE SUBMITTED WI...Accredited Consultants Private Limited 2023-10-07T11:18:49 2023-10-07T11:18:49
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1.4 If a manufacturer engages in only some oper...
