Customer complaint—Written, electronic or oral communication that alleges deficiencie ...

3.8 Design output means the results of a design effort at each design phase and at th ...

7.3.3 Design and development outputs: The outputs of design and development shall be ...

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

7.3.2 Design and development inputs: Inputs relating to product requirements shall be ...

PART IV INFORMATION REQUIRED TO BE SUBMITTED WITH THE APPLICATION FORM FOR IMPORT OR ...

Proposed instructions for use or electronic instructions for use and labels.] (b) Dat ...

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