Contract Development & Manufacturing · ISO 13485 · FDA Registered

One U.S. partner from concept to validated production.

UTP Solutions helps emerging medical device companies get to market faster and with less risk — combining in-house design & regulatory support, tooling, injection molding, precision machining, assembly, and supply chain management under one roof.

Trusted for regulated work
ISO 13485FDA RegisteredISO 9001IATF 16949ITARCMMC Level 1
One partner, one roof

Vertically integrated — concept to commercialization

Six capabilities, one accountable team. No re-sourcing between prototype and production.

01

Design & Regulatory

DFM, validation, risk

02

Tooling

Prototype → production

03

Injection Molding

Cleanroom & specialty

04

Precision Machining

Tight tolerances

05

Assembly

Value-added & sterile

06

Supply Chain

Sourcing, VMI, logistics

Why UTP

Built for emerging device companies

👷

Engineer-led

You talk to engineers who solve problems — not a call center or a quote queue.

🛡️

Regulatory discipline

ISO 13485, FDA, design controls and validation handled with audit-ready rigor.

🇺🇸

U.S. supply continuity

A domestic, single-source supply chain engineered to reduce your risk.

📊

Prototype → production

Scale from first tool to validated volume without changing partners.

22T–950T

Injection press range

ISO Class 8

Cleanroom molding

50yrs

Trusted by global brands

2 days

Engineer response time

Start the conversation

Talk to an engineer, not a call center.

Tell us what you're building and where you are. A UTP engineer responds within two business days — with real guidance, not a sales pitch.