UTP Solutions - Manufacturing for Regulated Industries

We provide US-based, Vertically Integrated Manufacturing Solutions for Regulated Industries. 50+ years of Engineering Expertise in Rapid Prototyping, Clean Room Injection Molding, Extrusion, Custom Tooling, CNC Machining, Integrated Electronics, and Automated Assembly has allowed us to consistently deliver safe, effective, and reliable devices. We partner with Life Science OEMs and Innovators to transform concepts into high-quality, market-ready devices. Our Design & Development and Manufacturing Transfer processes allow for speed in completing your DHF and FDA 510(k) Submissions, and manufacturing at scale while reducing supply chain risks. With decades of directly serving OEMs and Prime government contractors in Defense and Aerospace, we understand the engineering excellence, compliance, and speed required to ensure your devices and systems perform when it counts. Injection Molding Capabilities: Insert Molding | Over Molding | Multi-material 2-shot | Micro-molding | Color Match | Mold In Color | Gas Assist | 22T to 950T Press Tonnage Range | End of Arm | Automation Machine Shop: Custom Tooling | CNC Machining | Prototype and Production Volume Engineering Capabilities: Development and design loop support | Design Controls expertise Design for Manufacture (DFM) Support | MoldFlow Analysis Design History File (DHF) expertise | Technical File EU MDR Risk Management File (RMF) | ISO 14971 Expertise 510(k) submission services Validation for regulated industry (IQ/OQ/PQ) On-site QC Lab and Tooling | PPAP | MSA ISO 13485 | IATF 16949 | ISO 9001