Case Study: Rapid Requirements Review

A well-known large medical device manufacturer was developing a new diagnostic imaging device. The electromechanical/software support console was subcontracted to an outside engineering firm which further subcontracted the software development to another contractor. Shortly before design verification was scheduled to begin, the manufacturer was concerned that the three requirements documents developed by the three different engineering groups contained conflicting, duplicate, and/or missing requirements. The impact of not rectifying the situation could be unnecessary duplicate design verification testing and the possibility of needing to repeat testing should conflicting requirements be discovered during testing.

AlvaMed supplied a team of engineers experienced in requirements whom were able to quickly and thoroughly cross-check the various requirements documents provided by all three engineering groups.

The team identified duplicative, inconsistent, ambiguous, and missing requirements in less than two weeks, allowing the manufacturer to resolve the discrepancies before beginning design verification and giving them the assurance that their design verification would be as efficient as possible.
 

 Bob DiNitto
 Vice-President
 Quality Assurance,
 Regulatory Affairs,
 & Design Control