Design History files- Google Drive
Subfolder Contents include the following:
- Design input – Design inputs are typically the initial requirements that describe the device to be produced.
- Design output – Design outputs are the results of the design and engineering efforts. These are normally the final specifications for the device. Including the manufacturing process and the in-coming, in-process and finished device inspection, measurement or test methods and criteria. The outputs are normally documented in models, drawings, engineering analysis and other documents. The output needs to be directly traceable to the input requirements. Design verification and validation should demonstrate that the final output specifications conform to the input requirements and meet user needs and intended uses.
- Design review – The design review is a formal review of the device design by representatives of each design function participating in the design efforts as well as other interested parties (e.g. marketing, sales, manufacturing engineering, etc.). The design review must be documented in the DHF and include review date, participants, design version/revision reviewed and review results.
- Design verification – Design verification is the process that confirms that the design output conforms to the design input. Design verification should demonstrate that the specifications are the correct specifications for the design. Design verification must be documented in the DHF and include the verification date, participants, design version/revision verified, verification method and verification results.
- Design validation – Procedures for validating the device design. Design validation shall be performed under defined operating conditions on initial production units, lots, or batches, or their equivalents. Design validation shall ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions. Design validation shall include software validation and risk analysis, where appropriate. The results of the design validation, including identification of the design, method(s), the date, and the individual(s) performing the validation, shall be documented in the DHF