Planning 5.4.1 Quality objectives: Top management of the manufacturer shall ensure th ...

Finished device means any device or accessory to any device that is suitable for use ...

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

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

3.13 Quality audit means a systematic, independent examination of a manufacturer's qu ...

Control of records: Records shall be established and maintained to provide evidence o ...

Documentation requirements 4.2.1 General: Central Drugs Standard Control Organization ...

Analysis of data The manufacturer shall establish documented procedures to determine, ...