Design for Lean Applications
Specialized Design for Six Sigma tracks built for a specific kind of work, not a generic curriculum. First up: MedDFSS and GenDFSS.
Medical Design for Six Sigma
MedDFSS is a two-product family for medical-device Design for Six Sigma. Application builds the DFSS model. Audit checks whether company design records cover it. Neither product is the Design History File or the QMS of record.
Build the DFSS model from the start.
MedDFSS Application is a DFSS authoring workbench for medical-device teams. It walks device and process design through Define, Measure, Analyze, Design, Verify, Validate, and Transfer — with CTQs, tool worksheets, traces, and the evidence the team still needs to produce.
Official design records stay in the company’s document control system. Application does not replace the DHF, the DMR, or a Part 11 QMS. It prepares the model so the team does DFSS right before those records are issued.
See what the DHF and DMR actually cover.
MedDFSS Audit registers the company’s existing DHF and DMR documents, maps them to the DFSS evidence model, and reports coverage gaps, stale files, and missing traceability.
It does not become the Design History File. Teams keep issuing, approving, and retaining records in their own QMS. Audit tells them what is covered — and what is not.
How they work together
Author the model in Application. Export a handoff package. Import it in Audit to measure coverage against the files already under document control.
Methodology based on Design for Lean LLC. Preview only — not QMS of record.
Khalid S. Mekki, PhD, CSSMBB, co-author of Medical Device Design for Six Sigma (Wiley, 2008).
General Design for Six Sigma
A disciplined way to design something new.
For teams outside regulated industries who still need a disciplined way to design something new — a product, a service, or an internal process — instead of retrofitting tools built for fixing what already exists.
Want to know when these launch?
Tell us which application you're interested in and we'll reach out the moment it's ready.