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11.0 Analytical specificity: (i) This section should describe interference and cross react...

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(ii) Documents to be submitted with the application for grant of licence to manufacture or...

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

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Best Medical Licences. Professional Licenses: Many professions, such as doctors, lawyers, ...

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

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The manufacturer shall establish and maintain a record for each batch of medical device or...

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4.2.3 Control of documents : Documents required by the quality management system shall be ...

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7.0 Analytical Studies: The statements and descriptions in the following sections refer to...

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

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