Dan Joseph - Mechanical Engineer
A simple unit conversion program
FDA 21 CFR part 820
Design history file (DHF) means a compilation of records which describes the design history of a finished device.
Design input means the physical and performance requirements of a device that are used as a basis for device design
Design output means the results of a design effort at each design phase and at the end of the total design effort The finished design output is the basis for the device master record. The total finished design output consists of the device, its packaging and labeling, and the device master record.
Device master record (DMR) means a compilation of the records containing the production history of a finished device.
Validation means confirmation by examinati9n and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled.
Verification means confirmation by examination and provision of objective evidence that specified requirements have been fulfilled.