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

7.2 Bio-compatibility: (i) The dossier should contain a list of all materials in dire ...

7.0 Verification and validation of the medical device 7.1 General: (A) The dossier sh ...

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

Note: 1. All reports submitted as a part of the dossier should be signed and dated by ...

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

1.4 If a manufacturer engages in only some operations subject to the requirements of ...

7. Quality Assurance: Description of the quality assurance system and of the activiti ...