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(b) conformity with an in-house test method; (c) the evaluation of pre-clinical and clinic...

2023-09-14T05:01:44

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7.5.1.1 General requirements The manufacturer shall plan and carry out production and serv...

2023-10-17T05:26:07

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When evaluating a consulting firm, consider the factors mentioned earlier, such as their e...

2023-10-20T06:45:30

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4.2.2 Quality manual: The manufacturer shall establish and maintain a quality manual that ...

2023-10-10T04:30:57

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(b) the intended user (lay person or professional); (c) a general description of the princ...

2023-09-16T05:31:26

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5.0 Essential principles checklist: (i) The dossier should contain the following:— (a) the...

2023-09-14T05:00:57

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(i) for medical devices intended to emit ionizing radiation, information on radiation sour...

2023-09-14T04:57:28

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(3) If on receipt of the application and the report referred to in sub-rule (2), the Cent...

2023-08-28T05:26:06

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Note 2 : Provision of the medical device for purposes of clinical evaluations and/or evalu...

2023-10-13T05:22:38

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