We bridge from validated design to a stable, scalable, and auditable production capability that meets cost, quality, volume, and regulatory objectives.
What We Do
• Manufacturing readiness & gap assessments (MRL mapping) from TRL 6 prototypes to preproduction builds.
• Process development & validation (IQ/OQ/PQ or equivalent sector protocols); documentation to satisfy quality audits (e.g., ISO 13485, AS9100 clauses as applicable).
• Pilot line design, line balancing, takt time modeling, and automated test strategy.
• Tooling & fixture design; digital work instructions; operator training materials.
• Supply chain architecture: make/buy analysis; dual sourcing plans; critical parts risk mapping; secure supplier onboarding (ITAR/EAR, cybersecurity, ESG criteria).
• Data connectivity—PLM to MES/ERP integration for realtime configuration control, genealogy, and eDHR/eBOM traceability.
Outcomes for Stakeholders
• Qualified pilot builds that derisk launch capital commitments.
• Predictable yield curves; cost visibility before fullrate spend.
• Supplier and process packages ready for regulatory and customer audits.
