DESIGN HISTORY FILE REMEDIATION

Completion of a program to implement product design improvements prompted a major medical device manufacturer to update their DHF which did not keep pace with regulation or previous product changes. Dellshire SMEs worked with the management and technical teams to devise a product portfolio plan that would leverage required remediation work pertaining to Design Inputs. Products were then prioritized based on schedule and business impact, and work was initiated. On occasion, it was found that some requirements were needed that were not defined or understood. Dellshire led the effort to produce test samples, define and qualify inspection methods, and generate the data necessary to understand legacy product performance and define the Design Inputs.  This template was applied to all products in the product family, and once complete, the company was able to move forward and complete design verification on the improved product designs.