Connected Project Management for MedTech.
Plan, execute, and monitor product development programs, submissions, audits, CAPAs, remediation efforts, and commercialization initiatives in the same platform where the work happens.
Project plans remain connected to the workflows, records, requirements, risks, approvals, evidence, training, and submissions required to move regulated work forward.
Project Management connected to execution.
Stand up a launch from a blueprint, then track the Gantt, capacity, and critical path: connected to the documents, CAPAs, and submissions the work actually touches.
Project plans connected to real work.
Project plans connect to records, not to a separate PM tool. Capacity, blockers, and critical path stay aligned with where the work actually happens.
Gantt that knows the records
Tasks link to the DHF, CAPA, and document records they produce, not a PM tool reconciling spreadsheets.
Reusable blueprints
Bottle once: 510(k) launch, EU MDR readiness, MDSAP audit prep, CAPA campaign. Stamp instances per product.
Capacity & assignment
See who's loaded with what, across CAPAs, audits, design reviews, and product launches.
Critical-path watch
IQ-assisted schedule risk: surface slippage before it propagates.
Program dashboards
On-time vs. overdue, milestone health, blocker count, signature aging: saved per program template.
LuminLogic IQ embedded
Summarize a phase, draft a status note, propose a mitigation when a critical path slips.
A program, end to end.
Out-of-the-box blueprints for 510(k), EU MDR Class II/III, MDSAP audits, and CAPA campaigns: admin-configurable per product class.
Stamp from blueprint
Pick a blueprint, name the program, assign leads. Tasks and gates assemble automatically.
Execute
Owners work in their own modules. Projects keeps the dependencies and milestones in sync.
Track
Critical-path watch flags slippage early. IQ proposes mitigations linked to capacity reality.
Retrospect
Close-out package and lessons captured; blueprint updated for the next program.
Projects lives on the same platform as everything else.
Engineering & DHF
Design program tasks link to the DHF records they produce.
Learn moreSubmissions
Submission programs roll up section status from the DHF.
Learn moreCAPA
CAPA campaigns can be programmatized as recurring blueprints.
Learn moreWorkflows
Process workflows and program blueprints share the same engine.
Learn moreStop reconciling Smartsheet against the eQMS.
See a program blueprint stamp itself and run alongside live records, no copy-paste status updates.