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Significant expertise is needed to develop effective image-guided surgical applications.Development processes require a close connection between subject matter experts (SMEs) and software engineers.The accepted requirements are entered into the bug tracker and marked as “open.” Once the supporting software is implemented and its functionality is confirmed, the requirement is marked as ‘verified.” As the nightly builds takes place, all verified requirements are automatically archived and exported into Latex and PDF files via custom python scripts.A barrier to conceptualizing requirements is the disparity of knowledge between software engineers and clinicians.In our work, we introduce a customized extension to standard agile development techniques through the introduction of an agile requirements management method.Requirements define system constraints with an emphasis on the functionality that affects the end users.

In all cases, requirements must meet the rigor necessary to assure the reliability of target applications.

Waterfall and spiral development approaches tend to incorporate “top-down” processes that assume that complete requirements can be defined early in development.

In this domain, we discovered that development processes must tightly integrate iterative involvement of medical professionals and SMEs.

Maintenance Process A Maintenance process has been done to revise Permitted Daily Exposure (PDE), as new toxicological data for solvents become available.

Limit values for three residual solvents in drug products were revised on basis of the newly recognised toxicity data; lower PDE for N-Methylpyrrolidone being kept in Class 2 (limited by health-basis) and for Tetrahydrofuran and Cumene being placed into Class 2 from Class 3 (no health-based).

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