From Product Concept to Certified Mass Production
Thirty years of manufacturing track record, ISO-certified quality, and global regulatory support. One factory to take you from concept to mass production.
since 1996
Client Partnership
Quality System
How Can We Help You?
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 →An 18-Year Consumer Electronic Medical Device Partnership
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.
The Engineering Work We Complete In-House
- Mechanical & electronic R&D
- Industrial design support
- In-house tooling
- PCB/PCBA design & SMT
- Battery & power management
- Medical-grade laser modules
- UV-C modules
- Ultrasonic transducers (40 kHz)
- HEPA & negative-ion systems
- Micro motors
- Injection / blow / rotational molding evaluation
- Pre-production, in-process & final QC + third-party testing
What Happens After You Reach Out
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.
Three Things We Do Exceptionally Well
Consumer Electronic Medical Device OEM
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 →
Health & Wellness Appliances ODM
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 →
Consumer Electronics
PCB/PCBA design, SMT assembly, battery and power management: full electronics integration under one roof.
Explore electronics manufacturing →Certification Support for the Markets You Sell In
Quality Management
- ISO 13485:2016
- ISO 9001:2015
- D-U-N-S® Registered: 65-748-8375
Product Compliance Experience
- CE
- FCC
- RoHS
- PSE
- UL
- ETL
- CB
- CCC
- BSMI
- UN38.3
- SDS (MSDS)
Certification availability and requirements vary by product and target market. Every certificate is verifiable; scans available on request.
Send an Inquiry
Tell us what you're building. We will get back to you as soon as possible.
- Initial response within two business days
- NDA available before any technical discussion
- Design-for-manufacturing feedback with every quotation
- English-speaking engineering team