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7.3.3 Design and development outputs: The outputs of design and development shall be provi...

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Best Regulatory Affair in Delhi NCR. iv Recall Action Level: The level to which the recall...

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Design and development validation: Design and development validation shall be performed in...

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

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7.3.6 Design and development validation: Design and development validation shall be perfor...

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7.3.1 Design and development planning: The manufacturer shall establish documented procedu...

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If the product is cleaned in accordance with clause (a) or clause (b) above, the requireme...

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Purchasing information shall describe the product to be purchased, including where appropr...

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

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