Company lists · Data refreshed October 2026

Top 25 Iso 13485 manufacturers based in the United States

RevenueBase identified 248 company matches for iso 13485 manufacturers associated with the United States as of October 2026 and tracks 1,729 professional contacts across them, including 448 with verified work emails. Irvine is the largest hub.

This list covers company matches for iso 13485 manufacturers associated with the United States, found by RevenueBase SmartSearch using the meaning of business descriptions in its company graph at Exact. Ranked by professionals tracked, largest first. Rows show recorded descriptions where available, Exact search membership and the snapshot date. Data refreshed October 17, 2026.

Published by RevenueBase, a B2B data infrastructure company. This list was built with RevenueBase SmartSearch, the natural-language company search RevenueBase customers use to build their own targeted lists and unlock verified emails and direct dials at the companies on them. How these lists are built and judged.

How to read this list RevenueBase SmartSearch · Exact Recorded Oct 17, 2026 How this list was built
248Companies
1,729Contacts tracked
448Verified emails
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The 25 largest iso 13485 manufacturers based in the United States

Ranked by team size
Top 25 of 248 company matches for iso 13485 manufacturers based in the United States, ordered by professional contacts tracked in RevenueBase, largest first. Recorded Oct 17, 2026. The RevenueBase SmartSearch column shows Exact match membership in this saved search. Click a contact count to view that company's people. Totals use company locations recorded by RevenueBase; the displayed preview is a smaller selection.
#CompanyRevenueBase SmartSearchHeadquartersEmployeesContacts
1Exact matchCincinnati, OH, United StatesHQ recorded Oct 17, 202651-20091 contacts →

Exact match

“PMC SMART Solutions draws upon more than 90 years of manufacturing know-how and innovation to give customers a comprehensive, scientific approach to manufacturing technology that…”

Recorded in the RevenueBase company graph · Oct 17, 2026 · View company records in RevenueBase
2Exact matchDraper, UT, United StatesHQ recorded Oct 17, 202611-5043 contacts →

Exact match

“The Axeon Difference Axeon Corporation is a customer-focused, practical and approachable, technically sound training and consulting firm.”

Recorded in the RevenueBase company graph · Oct 17, 2026 · View company records in RevenueBase
3Exact matchAtlanta, GA, United StatesHQ recorded Oct 17, 202611-5035 contacts →

Exact match

“Rook Quality Systems is a consulting firm dedicated to helping early-stage medical device companies develop and maintain effective and efficient quality systems.”

Recorded in the RevenueBase company graph · Oct 17, 2026 · View company records in RevenueBase
4Exact matchMinneapolis, MN, United StatesHQ recorded Oct 17, 202611-5035 contacts →

Exact match

“Quality Auditing LLC is the industry leader in Quality Management System Auditing & Consulting for clients in highly-regulated industries, including Medical Device…”

Recorded in the RevenueBase company graph · Oct 17, 2026 · View company records in RevenueBase
5Exact matchPleasanton, CA, United StatesHQ recorded Oct 17, 2026501-1,00035 contacts →

Exact match

Recorded description not available.

Recorded in the RevenueBase company graph · Oct 17, 2026 · View company records in RevenueBase
6Exact matchCoral Gables, FL, United StatesHQ recorded Oct 17, 202651-20032 contacts →

Exact match

“Walking the regulatory compliance tightrope is not easy, but with the real-world quality expertise of BioTeknica, an IQVIA business, life science manufacturing clients gain a…”

Recorded in the RevenueBase company graph · Oct 17, 2026 · View company records in RevenueBase
7Exact matchEast Hanover, NJ, United StatesHQ recorded Oct 17, 202611-5028 contacts →

Exact match

“Viscot Medical, LLC has been committed to providing the healthcare industry with high quality disposable products at an economical price since 1974.”

Recorded in the RevenueBase company graph · Oct 17, 2026 · View company records in RevenueBase
8Exact matchOrlando, FL, United StatesHQ recorded Oct 17, 202611-5027 contacts →

Exact match

“QualityHub is a full-service regulatory, quality, and compliance consultancy for the highly regulated Medical Device, Pharmaceutical, Biologics, and Combination Products…”

Recorded in the RevenueBase company graph · Oct 17, 2026 · View company records in RevenueBase
9Exact matchOtsego, MN, United StatesHQ recorded Oct 17, 202651-20025 contacts →

Exact match

“An ISO9001_2015 and ISO13485:2016 company providing machining, manufacturing, and assembly services to a multitude of industries for over 35 years.”

Recorded in the RevenueBase company graph · Oct 17, 2026 · View company records in RevenueBase
10Exact matchLino Lakes, MN, United StatesHQ recorded Oct 17, 202611-5025 contacts →

Exact match

“Founded in 1988, Mountain Manufacturing Technologies is a leading research & development-driven contract manufacturer with a full range of machining and fabricating capabilities…”

Recorded in the RevenueBase company graph · Oct 17, 2026 · View company records in RevenueBase
11Exact matchHouston, TX, United StatesHQ recorded Oct 17, 202651-20025 contacts →

Exact match

Recorded description not available.

Recorded in the RevenueBase company graph · Oct 17, 2026 · View company records in RevenueBase
12Exact matchMooresville, IN, United StatesHQ recorded Oct 17, 2026201-50023 contacts →

Exact match

“Creative Foam Healthcare formally know as Mt.”

Recorded in the RevenueBase company graph · Oct 17, 2026 · View company records in RevenueBase
13Exact matchSan Diego, CA, United StatesHQ recorded Oct 17, 20261-1023 contacts →

Exact match

“NJK & Associates provides hands-on, action-based solutions to your Quality and Regulatory needs.”

Recorded in the RevenueBase company graph · Oct 17, 2026 · View company records in RevenueBase
14Exact matchAustin, TX, United StatesHQ recorded Oct 17, 20261-1022 contacts →

Exact match

Recorded description not available.

Recorded in the RevenueBase company graph · Oct 17, 2026 · View company records in RevenueBase
15Exact matchRiverside, CA, United StatesHQ recorded Oct 17, 202651-20021 contacts →

Exact match

“Trademark Plastics, Inc.(TPI) produces more than 300 different plastic, medical components for 8 of the top 30 Medical Device Manufacturers around the world.”

Recorded in the RevenueBase company graph · Oct 17, 2026 · View company records in RevenueBase
16Exact matchMiddlefield, OH, United StatesHQ recorded Oct 17, 202611-5020 contacts →

Exact match

“At Troy Innovative, it is our goal to provide our customers with high quality products at competitive prices.”

Recorded in the RevenueBase company graph · Oct 17, 2026 · View company records in RevenueBase
17Exact matchRoseville, MN, United StatesHQ recorded Oct 17, 202611-5020 contacts →

Exact match

“Fang Consulting is a medical device consulting firm specializing in Regulatory Affairs, Quality Assurance, and Engineering capabilities.”

Recorded in the RevenueBase company graph · Oct 17, 2026 · View company records in RevenueBase
18Exact matchWakefield, MA, United StatesHQ recorded Oct 17, 202611-5019 contacts →

Exact match

“A unique approach to design.”

Recorded in the RevenueBase company graph · Oct 17, 2026 · View company records in RevenueBase
19Exact matchEast Troy, WI, United StatesHQ recorded Oct 17, 202611-5017 contacts →

Exact match

“CaP Biomaterials is an ISO13485:2016 certified contract manufacturer of calcium phosphate biomaterials for use in medical devices.”

Recorded in the RevenueBase company graph · Oct 17, 2026 · View company records in RevenueBase
20Exact matchTustin, CA, United StatesHQ recorded Oct 17, 202651-20017 contacts →

Exact match

“ClearPath Medical is an experienced custom engineering and manufacturing company of high-quality medical interconnect systems for Diagnostic, Therapeutic, and Surgical medical…”

Recorded in the RevenueBase company graph · Oct 17, 2026 · View company records in RevenueBase
21Exact matchSan Antonio, TX, United StatesHQ recorded Oct 17, 2026201-50017 contacts →

Exact match

“Coastal Life Technologies is your single-source solution for the manufacturing and distribution of finished medical devices - from development to routine production and beyond.”

Recorded in the RevenueBase company graph · Oct 17, 2026 · View company records in RevenueBase
22Exact matchNeedham, MA, United StatesHQ recorded Oct 17, 202611-5016 contacts →

Exact match

“AlvaMed is a medical device consulting and outsourcing organization.”

Recorded in the RevenueBase company graph · Oct 17, 2026 · View company records in RevenueBase
23Exact matchEast Troy, WI, United StatesHQ recorded Oct 17, 202611-5016 contacts →

Exact match

“ISO 13485:2016 & EN ISO 13485:2016 Certified.”

Recorded in the RevenueBase company graph · Oct 17, 2026 · View company records in RevenueBase
24Exact matchFortville, IN, United StatesHQ recorded Oct 17, 202651-20016 contacts →

Exact match

“Genesis Plastics Welding, a division of Vonco Products, LLC, an Indiana-based ISO 13485-certified contract manufacturer specialized in the art of radio frequency (RF) welding and…”

Recorded in the RevenueBase company graph · Oct 17, 2026 · View company records in RevenueBase
25Exact matchFort Worth, TX, United StatesHQ recorded Oct 17, 202651-20015 contacts →

Exact match

“Nurse Assist manufactures the highest quality products used by hospitals and nursing homes.”

Recorded in the RevenueBase company graph · Oct 17, 2026 · View company records in RevenueBase

Showing 25 of 248 iso 13485 manufacturers based in the United States

See the full list, filter by size, metro and specialty, and access 448 tracked professional contacts with verified work emails. Direct dials are available where recorded.

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Iso 13485 manufacturers based in the United States at a glance

As of Oct 17, 2026
25.9%Verified-email coverage
7.0Average contacts per company
1-10Median size (employees)
2.0%Largest-city concentration · Irvine
Oct 17, 2026Page data refreshed

Companies by employee count

1-10
162
11-50
56
51-200
22
201-500
4
501-1,000
4

Email recency for this list is measured worldwide rather than for United States, so it is reported there. Company counts and contact totals on this page are exact for United States, over 248 companies.

How this list was built

The recorded descriptions help you assess these company matches. Check a company’s website for its current services and locations.

Source
The RevenueBase company graph: 60 million companies and 398.9 million professional contacts resolved from primary sources, queried with RevenueBase SmartSearch, the natural-language company search available to every RevenueBase user.
What qualifies
Company records associated with the United States whose business descriptions match “iso 13485 manufacturers” by meaning at the Exact setting. Descriptions are compiled in the RevenueBase company graph from public websites, profiles and company information where available; they are not guaranteed quotations from the company's website.
RevenueBase SmartSearch
Describe a niche company in your own words to find businesses by meaning. Exact, Similar, Related and Broad control the breadth of RevenueBase SmartSearch. This saved list uses Exact. Each row's Exact match badge shows inclusion in that search, not an individual score or a service-quality judgment.
Public preview
The public preview omits records without a verified work email. Where headquarters information is recorded, preview rows are also filtered to this page’s location. Dataset totals and geographic summaries describe the full matched records before these preview filters.
Match quality
RevenueBase's August 25, 2026 study assessed 4,198 description/company pairs across matching settings. The publisher reports 86% good or better at Exact. This evaluates the method across queries; it does not audit this individual list. Recorded company descriptions, where available, help you judge each match yourself. Read the full methodology: how the lists are built and what the study measures.
Ranking
Team size, largest first: companies are ordered by the number of professionals RevenueBase tracks at each one. Employee ranges shown are reported bands, for context.
Verification
Every displayed company carries at least one verified work email. RevenueBase tracks 448 professional contacts with verified work emails across the full matched dataset. Contacts re-verify on a rolling cadence, and each contact's own verification date is shown inside RevenueBase.
Refresh
This page's figures were pulled from the company graph on October 17, 2026. Lists refresh periodically as the graph is re-checked.
Record context
Company records and descriptions can change. Check the company's website for its current services and locations.

Frequently asked

What is RevenueBase SmartSearch?

RevenueBase SmartSearch finds niche companies by the meaning of their business descriptions in the RevenueBase company graph. Exact, Similar, Related and Broad control how closely companies must fit your description. This list uses Exact for “iso 13485 manufacturers”; each Exact match badge shows search membership, not an individual similarity or quality score.

How many iso 13485 manufacturers are there based in the United States?

RevenueBase identified 248 company matches for iso 13485 manufacturers associated with the United States as of October 2026, using the meaning of business descriptions at Exact. This is the recorded matched set in the RevenueBase company graph.

What is the largest company on this list?

PMC Smart Solutions tops the displayed preview by professional contacts tracked in RevenueBase. Recorded headquarters appear in the company rows.

Which city has the most iso 13485 manufacturers?

Irvine leads with 5 company records, followed by San Diego (5) and San Jose (5).

How do I get contact information for these companies?

A free RevenueBase account lets you run this exact search and work limited free results with 500 credits to start. Upgrading provides access to the 448 professional contacts with verified work emails tracked across these 248 companies; direct dials are available where recorded.

How current is this list?

The list refreshes periodically as the company graph is re-checked. This page's figures were pulled on October 17, 2026.

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About this data

RevenueBase is a B2B data infrastructure company. Its company graph covers 60 million companies and 398.9 million professional contacts, with emails verified on a rolling cadence rather than scraped once and left to decay. These company lists are generated directly from that graph with RevenueBase SmartSearch, the same natural-language company search every RevenueBase user has: describe a market in plain words, get the companies that match, and add verified emails and direct dials for the people at them. It is the same data that powers RevenueBase's B2B data products, and a free account includes 500 credits to start. How these lists are built and judged.