5.4 Planning 5.4.1 Quality objectives: Top management of the manufacturer shall ensur ...

(C) devices notified from time to time under sub-clause (iv), of clause (b) of sectio ...

And whereas, all objections and suggestions received in response to the said draft no ...

(b) the modification of a medical device and in vitro diagnostic medical devices; (c ...

PROVIDED that the requirement of Transmissible Spongiform Encephalopathies (TSEs) or ...

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

2. Applicability: The provisions of this Schedule shall be applicable to manufacturer ...

6.3 Infrastructure The organisation shall determine, provide and maintain the infrast ...