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

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

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

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(iii) a table compiling all observed device deficiencies that could have led to a serious ...

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Sponsor or manufacturer Name and address of the sponsor or manufacturer of the investigat...

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Actions taken in reporting interval for safety reasons: This section of PSUR shall include...

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Device description and product specification, including variants and accessories 2.1 The d...

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CONTENTS OF A SITE OR PLANT MASTER FILE The manufacturer shall prepare a succinct document...

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LABELLING OF MEDICAL DEVICES 44. Labelling of medical devices The following particulars s...

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