Thirty years of manufacturing track record, ISO-certified quality, and global regulatory support. One factory to take you from concept to mass production.
In 2008, a leading U.S. hair-growth device brand chose Gooten to manufacture their first home-use laser device. Eighteen years later, we co-develop their next generations, from industrial design and engineering to certification support and turnkey delivery.
We also build for a U.S. photomedicine device developer (clinical and home-use light-therapy systems), among the brands we serve across the US, Europe, and Japan.
33-point DFX review
Before tooling, we review manufacturability, sourcing, and testing risks across 33 checks. Each receives a red, yellow, or green rating. An unresolved red stops the project from advancing.
Production-proven platforms
Our Clean Life range brings production experience in UV-C, ultrasonic cleaning, and air care to your application. Together, we review the platform fit, agree on customization scope, and identify the verification each change needs.
Start from a concept or one of our proven product platforms. In-house industrial design, mechanical and electronic engineering take it from sketch to certified product.
Explore ODM → OEM: I Have Drawings or SpecificationsSend your design, BOM, and production requirements. Our engineers review them for manufacturability and reply with a grounded proposal.
Explore OEM → Private Label: I Need a Ready-to-Market ProductPut your brand on an engineered, production-proven platform: air purification, water filtration, UV-C sanitizing, and baby care.
Explore private label →NDA available before any technical discussion. Engineers review your brief. Initial response within two business days.
Positioning, competitive, and user-needs analysis feed a concrete engineering proposal and project plan.
Design-for-manufacturing feedback with every quotation; tooling and T1 samples validated against your spec.
Pilot run under the ISO 13485 quality system, with documentation and testing support for the markets you sell in.
ISO-certified QC at every stage (pre-production, in-process, and final inspection), through global delivery.
Consumer electronic medical device contract manufacturing under an ISO 13485 quality system, with dedicated assembly lines and documentation support for FDA-cleared home-use devices.
Explore medical manufacturing →
In-house R&D for air purification, water filtration, UV-C sanitizing, and baby-care devices, engineered and private-label ready for your brand.
Explore appliance ODM →
PCB/PCBA design, SMT assembly, battery and power management: full electronics integration under one roof.
Explore electronics manufacturing →Certification availability and requirements vary by product and target market. Every certificate is verifiable; scans available on request.
Tell us what you're building. We will get back to you with an initial response within two business days.
