Design for manufacturability and design transfer support for medical devices
DFM reviews, in-house mold-fill simulation, DFMEA and PFMEA, CAD and part design, and support for your risk file and design history file, from engineers who have worked on the OEM side.
UTP Solutions provides design for manufacturability (DFM) reviews, in-house mold-fill simulation, DFMEA and PFMEA, and design transfer support for medical device and automotive programs. Engineers review parts before tooling, simulate fill, pack and cooling, and support customers' ISO 14971 risk files and design history files during design transfer. UTP also creates CAD models from legacy prints or physical parts and designs parts for medical and automotive customers. Validation runs as IQ, OQ and PQ under an Integrated Management System certified to ISO 13485 and aligned with FDA's QMSR.
Engineering services
| DFM reviews | Manufacturability review of parts and assemblies before tooling: wall thickness, draft, gating, tolerances, materials and cost drivers |
|---|---|
| Mold-fill simulation | In-house fill, pack, cooling and warp analysis to set gate locations and cooling before steel is cut |
| Risk analysis | DFMEA and PFMEA prepared or supported for customer programs |
| Design transfer | Support for ISO 14971 risk files and design history files (DHF) as designs move into production |
| CAD and reverse engineering | CAD models created from legacy prints or physical parts |
| Part design | Part design for medical device and automotive customers |
| Validation | IQ / OQ / PQ · first article inspection · SPC |
Why engineering up front pays off
Most cost and schedule problems in a device program are designed in long before the first part is molded. A draft angle that won't release, a wall that sinks, a tolerance the process can't hold: each one is cheap to fix in CAD and expensive to fix in steel.
UTP's engineers review your design with the tooling, molding and machining teams that will build it, then carry your requirements through design transfer so nothing is lost in the handoff between your design team and production.
- OEM-side experience. Our team has worked through design controls, human factors and launch from the device company's side.
- Simulation before steel. Mold-fill simulation runs in-house, so results feed straight into the tool design.
- Requirements that survive transfer. Risk files, DHF inputs and validation plans stay connected to the production process.
Design and engineering questions
Does UTP offer DFM reviews?
Yes. UTP engineers review parts and assemblies for manufacturability before tooling, covering geometry, tolerances, gating, materials and cost drivers.
Does UTP run mold-fill simulation in-house?
Yes. Fill, pack, cooling and warp analysis are run in-house to guide gate location and tool design before steel is cut.
Can UTP support our ISO 14971 risk file and DHF?
Yes. UTP supports customers' ISO 14971 risk files and design history files during design transfer, and prepares or supports DFMEA and PFMEA.
Can UTP create CAD from an old print or a sample part?
Yes. UTP creates CAD models from legacy prints or physical parts.
Does UTP design parts?
Yes. UTP designs parts for medical device and automotive customers.
Talk to an engineer, not a call center.
Send the model or drawing. A UTP engineer replies within two business days with manufacturability feedback.