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

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

3.6 Component means any raw material, substance, piece, part, software, firmware, lab ...

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

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

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

5. Sanitation: Availability of written specifications and procedures for cleaning the ...

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