Stage 3
Design Transfer
From validated design to FDA-ready Design History File, Device Master Record, and a manufacturing package that's been built in Ranfac's own production format.
Design Transfer is the bridge between "we have a working prototype" and "we can manufacture this at clinical or commercial scale." Ranfac produces the full regulatory documentation set, validates manufacturing processes against your design, and delivers a first article — all formatted to flow directly into Ranfac's manufacturing line if you choose to produce here.
Three tiers
- Design History File structure
- Design inputs and outputs documentation
- Risk file scaffold (ISO 14971)
- Documents only — no V&V or first article
For companies with existing engineering capacity that need the regulatory shell.
- Complete DHF and DMR
- Risk file with hazard analysis
- Verification and validation plans
- First article and process validation
- Manufacturing Readiness Package
Replaces $200K–$500K consulting engagements.
- Everything in Full Design Transfer
- Extended biocompatibility and sterilization validation
- Higher-risk regulatory submissions support
- Multi-site or partner-integration scope
Priced per scope. Class III devices, novel materials, complex submissions.
Manufacturing pull-through advantage
If you choose to manufacture at Ranfac (Stage 4), 50% of your Design Transfer fee credits against your first manufacturing PO — roughly $75K back on a standard $150K engagement. The DHF is produced in Ranfac's manufacturing format, so transfer into production takes weeks instead of months.
No coercion: if Ranfac isn't a manufacturing fit, you keep the DHF and we equip you to source elsewhere via RFQ services.
Request a Design Transfer scope
Currently in private preview. Customers typically enter Design Transfer after completing a Feasibility Sprint.