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2.0 Device description and product specification, including variants and accessories 2.1 T...

2023-09-14T04:54:40

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2.0 Device description and product specification, including variants and accessories 2.1 T...

2023-09-13T05:26:51

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7.7 Animal studies: (i) Where studies in an animal model have been undertaken to provide e...

2023-09-16T04:53:32

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7.7 Animal studies: (i) Where studies in an animal model have been undertaken to provide e...

2023-09-16T04:51:42

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Appendix I CONTENTS OF A SITE OR PLANT MASTER FILE The manufacturer shall prepare a succin...

2023-09-12T05:11:41

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Note: Configuration management is a means by which identification and traceability can be...

2023-10-17T05:40:48

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1.1 Introductory descriptive information on the in vitro diagnostic medical device, the in...

2023-09-16T05:04:26

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7.2 Bio-compatibility: (i) The dossier should contain a list of all materials in direct or...

2023-09-16T04:43:15

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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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