Qualitex
Qualitex is a U.S.-based ISO 13485 and FDA-registered precision contract manufacturer providing CNC machining, gages and fixtures, and ISO 17025 accredited inspection for medical device, automotive, appliance, agricultural, and aerospace OEMs.
- Company typePrivate
- Founded1993
- HeadquartersColumbia City, United States
- Headcount11–50
- GTM typeB2B
- OfferingHardware or Manufacturing
What Qualitex does
Qualitex is a U.S.-based precision contract manufacturer (Qualitex Inc.) operating from Columbia City, holding a four-stack regulatory posture: ISO 9001:2015, ISO 13485:2016, FDA Registered, and ISO 17025:2017 (laboratory accreditation). Its core offering integrates CNC machining, gage and fixture design/build/certification, and ISO 17025-accredited inspection under a single roof, supported by CMM and optical comparator equipment. The product set comprises Medical Devices (including a specialized Spine sub-category), Machining, Gages & Fixtures, Inspection Services, Rapid Prototyping, and Full Assemblies, taking customers from prototype through production. Verticals served are Medical Device (primary), Automotive, Appliance, Agricultural, and Aerospace.
The company employs 11-50 people and reports 16 years in operation. Named enterprise customers span medical device OEMs Enovis, Paragon28, Skeletal Dynamics, and JJ (Johnson & Johnson), together with a long-tenured Tier 1 automotive supplier in Michigan and medical OEMs in Indiana and Tennessee. Cumulative production disclosed on the company website includes 35,815 external fixation rings, 6,800 surgical instruments, 12,722 custom gages/fixtures/tooling, and 53,100 third-party-inspected parts.
Qualitex's go-to-market is direct enterprise field sales, working "from large OEMs down to startups," with quote-based pricing that is not publicly disclosed. Revenue mechanics are contract manufacturing services priced per project and per part, supplemented by professional-services revenue from accredited third-party inspection. Operating geography is domestic (Midwest US). Material data gaps in the available source material include disclosed revenue, ownership structure, management team detail, and funding history.
Qualitex firmographics
Firmographics- Name
- Qualitex
- Legal name
- Qualitex Inc.
- Website
- https://qualitexinc.net
- Company type
- Private
- Founded year
- 1993
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- Qualitex is a U.S.-based ISO 13485 and FDA-registered precision contract manufacturer providing CNC machining, gages and fixtures, and ISO 17025 accredited inspection for medical device, automotive, appliance, agricultural, and aerospace OEMs.
- Ownership category
- akta.pro rank
Where Qualitex is headquartered
LocationHeadquarters
- HQ city
- Columbia City
- HQ country
- United States
- HQ region
- North America
Markets served
Qualitex business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Personnel, Operations, Supply Chain, Technology or R&D, Infrastructure
Revenue model
- Contract Manufacturing Services: Production manufacturing of single components up to full assemblies for Medical, Automotive, Appliance and Agricultural industries. Includes rapid prototyping through full production.
- Inspection Services: ISO 17025 accredited laboratory providing inspection services for outside customers. CMM, optical comparator and inspection equipment services.
Go-to-market motion1 record
Distribution channels1 record
Marketing channels3 records
Qualitex product offering
Product offeringCore offering
Qualitex is an ISO 9001, ISO 13485 and FDA Registered contract manufacturing facility that produces precision components and full assemblies through CNC machining. It designs, builds and certifies production-ready gages and check fixtures, and runs an ISO 17025 accredited inspection laboratory offering CMM and optical comparator measurement services for outside customers. Core end markets served are Medical Device, Automotive (Tier 1), Appliance, Aerospace and Agricultural industries, from rapid prototyping through full production.
Product overview
Qualitex is an ISO 9001, ISO 13485 & FDA Registered contract manufacturing facility offering a comprehensive suite of precision manufacturing services. The core offering consists of Medical Devices (including specialized Spine Products), Machining, Gages & Fixtures, and Inspection Services. The company supports the full product lifecycle from Rapid Prototyping through production to full Assemblies, serving Medical, Automotive, Appliance, and Agricultural industries. Their ISO 17025 accredited inspection laboratory provides quality verification throughout the manufacturing process.
Differentiator
Problem solved
Functional benefit
Products and services
- Medical Device Contract Manufacturing ISO 9001, ISO 13485 and FDA Registered contract manufacturing of medical devices such as spine products, surgical instruments, and external fixation rings, serving large OEMs and startups from prototyping through production parts.
- Machining Precision CNC machining (milling and turning) of components and assemblies for medical, automotive, appliance and agricultural industries, including rapid prototyping through full production.
- Gages & Fixtures Design, build, and certify production-ready Gage and Check Fixtures supporting metal stampings to injection molded parts for the Automotive, Medical, and Appliance industries.
- Inspection Services ISO 17025 accredited laboratory providing quality inspection using multiple Coordinate Measuring Machines (CMM), optical comparator, and supporting inspection equipment for both internal manufacturing verification and outside customers.
- Spine Products Manufacturing Specialized contract manufacturing of spine-related medical devices within Qualitex's medical device portfolio, supporting spine implant and surgical instrument production under ISO 13485 and FDA Registered processes.
Quantifiable outcome
- 53,100 parts inspected for outside customers through quality labs
- +1 more outcomes
Companies that use Qualitex
Customer profileNamed customers7 records
Segments5 records
Ideal customer profiles4 records
Qualitex technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature4 records
Qualitex partnerships and signals
Strategic signalScale indicators5 records
Recent moves5 records
Expansion highlights3 records
Qualitex competitors and assessment
Company assessmentDirect peers
- Tegra Medical: Precision medical device contract manufacturer offering CNC machining, assembly, and finished devices for medical OEMs — directly comparable to Qualitex's medical contract manufacturing focus and customer base.
- Norman Noble: High-precision CNC machining and contract manufacturing for medical implants and devices — directly comparable in the precision medical contract manufacturing niche Qualitex serves.
- Donatelle: Medical device and precision contract manufacturer with ISO 13485 certification and capabilities spanning prototyping to production — closely comparable to Qualitex's full-lifecycle service model.
- Mack Molding: Contract manufacturer offering plastic injection molding, machining, and assembly for medical and industrial customers — similar full-lifecycle service model and multi-vertical customer mix.
- J-Pac Medical: Medical device contract manufacturer and OEM specializing in implantable components, packaging, and assembly — directly comparable medical CMO with similar FDA-regulated, ISO 13485-certified operations.
Broad incumbents
- Integer Holdings: One of the largest medical device contract manufacturers globally, offering a broad portfolio across cardio, vascular, and orthopedics — broad incumbent in the same medical CMO space where Qualitex competes.
- Plexus Corp. Global contract manufacturer with a significant healthcare and medical device vertical — broader-scale incumbent serving medical OEMs with design, prototyping, and manufacturing services.
- Jabil Healthcare: Global contract manufacturer with a large healthcare and medical device business — broad incumbent with overlapping medical contract manufacturing capabilities at significantly greater scale.
Market position
Strengths4 records
Weaknesses4 records
Competitive moat4 records
Key risks5 records
Key highlights5 records
Customer concentration
Qualitex social profiles
Digital presenceQualitex compliance and trust
Trust signalCompliance4 records
Qualitex financial estimates
Financial estimateRevenue estimate
Valuation estimate
Qualitex leadership team
Management profileNumber of profiles
Qualitex funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Qualitex M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Qualitex
What does Qualitex do?
Qualitex is an ISO 9001, ISO 13485 and FDA Registered contract manufacturing facility that produces precision components and full assemblies through CNC machining. It designs, builds and certifies production-ready gages and check fixtures, and runs an ISO 17025 accredited inspection laboratory offering CMM and optical comparator measurement services for outside customers. Core end markets served are Medical Device, Automotive (Tier 1), Appliance, Aerospace and Agricultural industries, from rapid prototyping through full production.
Is Qualitex a public or private company?
Qualitex is a private company. It is classified as unknown and is currently operating.
When was Qualitex founded?
Qualitex was founded in 1993. It employs 11 to 50 people.
Where is Qualitex based?
Qualitex is headquartered in Columbia City, United States, in the North America region.
How does Qualitex make money?
Two revenue lines are on record. Contract Manufacturing Services are the primary driver. The others are inspection Services.
Who are Qualitex's main competitors?
Direct peers on record are Tegra Medical, Norman Noble, Donatelle, Mack Molding and J-Pac Medical. Broad incumbents are Integer Holdings, Plexus Corp. and Jabil Healthcare.
Does Qualitex have an API?
No public API is recorded for Qualitex.