MDx PCR Assay Cartridge: Manufacturing Line

MDx Assay Cartridge: Manufacturing Line.

Outome of this project was a validated manufacturing line for a small, room-temperature stable in-vitro-diagnostic assay cartridge with assay for diagnosis of an infectious-disease. The cartridge is launched as CE IVD in Europe, and FDA trials in the USA are ongoing.
My role in this project:

Planning facility layout & capital investment
Manufacturing cost analysis as basis for transfer price negotiations
Smooth know-how transfer from the international project partner & Project Management
Specifying manufacturing equipment & support in selecting specific part/components
Manufacturing layout according lean manufacturing principles
Annual capacity calculation & Expansion planning
Proposals for cost optimization
Guidance & support in ensuring compliance to applicable quality regulations (ISO13485 & FDA 21 CFR 809)