About us
A woman-owned manufacturer built on hands-on expertise
Founded in May 1996 in Elbert, Colorado, Custom Manufacturing Incorporated has spent nearly three decades producing medical and non-medical devices for companies that need flexibility without giving up quality.
Our story
Nearly 30 years of custom builds
Custom Manufacturing Incorporated is a woman-owned small business located in Elbert, Colorado. We specialize in non-automated manufacturing, assembly, and packaging to ensure the highest quality and allow for production flexibility.
With over 100 years of combined industry experience, our manufacturing capabilities include single-use and disposable medical devices, electro-surgical devices, cardiac insulation pads, and non-medical devices. Our custom services can accommodate simple or complex assembly.
Relationships are the measure we care about most: client retention averages 25+ years per client, and our past performance includes Covidien, Medtronic, Integra LifeSciences, and Viant Medical. Owner Jessica Mead leads a team that treats every program as a long-term partnership.
Our quality commitment
We are blueprint-to-production ready and operate under an ISO 13485:2016 certified quality management system in an FDA registered facility. Non-disclosure agreements protect every client program, and finished-product designs remain entirely yours.
Woman-owned small business
What WOSB certification means for your contract
CMI is WBENC-certified and approved under the SBA WOSB Federal Contracting Program, and is a Verified FedLinks federal vendor.
Sole source opportunities
Eligible for sole-source awards under the SBA WOSB Federal Contracting Program.
Pricing benefits
Set-aside contracting can improve competitive positioning on federal solicitations.
Market access
Access to federal and corporate supplier diversity programs and buyers.
Evaluation preference
Diversity spend goals can weigh in our favor during bid evaluation.
PR enhancement
Partnering with a certified WOSB strengthens supplier diversity reporting.
Economic development
Supports women-owned business growth and local Colorado employment.
Certifications
Verified, audited, documented
ISO 13485:2016 Certified QMS
Our quality management system is certified by NQA to ISO 13485:2016 for the manufacture, assembly, and packaging of medical devices.
ISO 14644-1:2015 Cleanroom
Our ISO Class 7 Controlled Environment cleanroom is certified per ISO Standard 14644-1:2015 for cleanroom packaging and sealing.
FDA Registered Facility #1721251
Registered with the U.S. Food and Drug Administration as a medical device establishment.
WOSB / WBENC Certified
WBENC-certified woman-owned business, approved under the SBA WOSB Federal Contracting Program and a Verified FedLinks federal vendor.
Let's get in touch
Ready to move from blueprint to production?
Tell us about your device, assembly, or packaging program. We'll review your requirements and respond with a scoped quote — NDAs available on request.