4.0 Design and manufacturing information: 4.1 Device Design: The dossier should conta ...

Design and manufacturing information: 4.1 Device Design: The dossier should contain i ...

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

Top management of the manufacturer shall ensure that responsibilities and authorities ...

Management representative: Top management shall appoint a member of management who, i ...

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

Internal communication: Top management shall ensure that appropriate communication pr ...

4.2 Documentation requirements 4.2.1 General: The quality management system documenta ...