Lateral-flow IVD cassette — design transfer in 14 weeks
FDA pre-sub filed on time; first-article PPAP accepted on first submission
Medical diagnostics· Series-B startup
Problem. Diagnostics startup had a working prototype but no FDA-ready DMR. They needed a contract manufacturer who could take their CAD files and deliver validated production parts before their FDA pre-submission deadline.
Solution. Full design transfer: DFM review caught two parting-line issues, mold-flow simulated, single-cavity validation tool built in 6 weeks, IQ/OQ/PQ executed inside the ISO 7 cleanroom. Delivered DMR + DHF aligned with 21 CFR Part 820.