Stage 10 of 12
Manufacturing transfer
Establish repeatable production, tooling, suppliers, and process controls.
Entry criteria
- The product design and bill of materials are controlled
- Manufacturing partners and sites are selected
- Quality and regulatory transfer requirements are defined
Required activities
- Complete DFM, tooling, fixtures, and work instructions
- Qualify suppliers and incoming controls
- Validate special processes and production software
- Run pilot builds and establish acceptance sampling
Expected deliverables
- Device master and manufacturing records
- Qualified tooling and suppliers
- Process validation reports
- Pilot build and yield evidence
Recommended capabilities
Look for providers with relevant device, market, and stage experience—not capability labels alone.
Common risks
- Uncontrolled knowledge transfer
- Yield and tolerance issues appearing at production scale
- Single-source or long-lead component exposure
Exit criteria
- Production processes consistently meet specifications
- Suppliers, equipment, and special processes are qualified
- Release, traceability, and nonconformance controls are operating
Suggested next actions
- Authorize the launch build
- Confirm inventory and distribution readiness
- Activate post-market monitoring
Find your next move
Build confidence in manufacturing transfer.
Map your current evidence and gaps to the capabilities needed for this stage.