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6.3 Infrastructure The organisation shall determine, provide and maintain the infrastructu...

2023-10-11T04:46:54

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This summary may include: (a) Where a recognized standard exists, a declaration/certificat...

2023-10-03T05:13:09

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5.6.2 Review input: The input to management review shall include information on— (a) resul...

2023-10-11T04:40:16

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4.2.4 Control of records: Records shall be established and maintained to provide evidence ...

2023-10-10T04:35:16

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These processes shall be managed by the manufacturer in accordance with the requirements o...

2023-10-10T04:27:15

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FIFTH SCHEDULE [Refer rules 20(3), 20(5), 20(8), 22(i)] QUALITY MANAGEMENT SYSTEM FOR MEDI...

2023-10-06T04:27:44

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19.0 Clinical Evidence: The device master file should contain the Clinical Evidence, Evalu...

2023-10-05T05:32:49

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9.2 Reproducibility: This section should include reproducibility estimates and information...

2023-10-04T04:23:16

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(ii) Detailed information: Detailed information should include: (a) complete study protoco...

2023-10-03T05:22:30

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