From Product Concept to Certified Mass Production
Gooten helps global brands develop medical, wellness, and precision electronic products — from industrial design, mechanical and electronic engineering to tooling, certification support, and mass production.
— since 1996
Client Partnership
Quality System
— business days
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 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
Medical Device OEM
Medical device contract manufacturing under an ISO 13485 quality system — 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. An engineer — not a sales bot — will get back to you.
- Initial response within two business days
- NDA available before any technical discussion
- Design-for-manufacturing feedback with every quotation
- English-speaking engineering team