21 CFR Part 820 Compliant 30 Years Experience

We Make Healthcare Run Better

By delivering improved clinical, financial and operational outcomes through quality medical assemblies

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CMS Cleanroom Facility

OUR FACILITY

ISO Class 8
Cleanroom Manufacturing

Our products are assembled, packaged, and shipped from our North Carolina facility. Every item is handled in a strictly controlled ISO Class 8 cleanroom environment to ensure the highest level of safety and quality.

Certifications held by Custom Assemblies, Inc.

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CMS Best Sellers

Our top-selling products ordered by hospitals and surgical centers every day.

Trusted by Healthcare Facilities Nationwide

See why medical professionals choose us for their critical supply needs

ISO Class 8
Woman-Owned
Assembled in NC

"We've been ordering from Custom Assemblies for over 8 years. Their quality is consistent, delivery is always on time, and their customer service is exceptional."

Sarah M.
Procurement Director, Regional Medical Center

"The custom procedure kits we designed with Custom Assemblies have improved our OR efficiency significantly. Their team worked closely with us to create exactly what we needed."

Dr. James Hawker.
Chief of Surgery, University Hospital

"Switching to Custom Assemblies was one of our best decisions. Their same-day shipping has been a lifesaver during supply shortages, and their pricing is very competitive."

Michael Debour
Supply Chain Manager, Outpatient Clinic Network

Ready to Partner With Us?

Custom medical equipment manufacturing with ISO Class 8 cleanroom facilities. Woman-owned and proudly made in North Carolina.

Trusted by 43,000+ healthcare facilities nationwide