The Design History file should contain all of the documentation created during the product development phase of your medical device. Following are design controls process which will help you understand what documents are required for DHF. Each step of design control processes generates its own documentation.
Design and development planning – D& D planning contains design plan document.
- Design input – Design input includes procedures for establishing design input that addresses the intended use and user needs
- Design output – Design Output includes the procedure for defining and documenting design output in compliance with this part, and the approved design output documentation itself.
- Design review – Design Review contains procedure for conducting reviews of your design process and any documentation related to the reviews that were conducted.
- Design verification – Design Verification includes a document describing your design validation process and the approved results of the design validation.
- Design validation – Design validation consists of specific procedure and testing conditions used for design validation, as well as the approved results of the design validation process.
- Design transfer – Design transfer includes the documented product specifications that are developed in compliance with this part and a description of the process used.
- Design changes –Design changes contains documented design change process and documentation pertaining to any design changes that have taken place.
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