Company lists · Data refreshed September 2026

Top 25 Medical device regulatory software companies based in the United States

Name: Medical device regulatory software companies based in the United States
Creator: RevenueBase
License: https://creativecommons.org/licenses/by/4.0/

Compiled by the RevenueBase Data Team Data refreshed Sep 28, 2026 882 companies tracked

RevenueBase identified 882 medical device regulatory software companies headquartered in the United States as of September 2026 and tracks 15,764 professional contacts across them, including 5,401 with verified work emails. Austin is the largest hub.

This list covers medical device regulatory software companies headquartered in the United States, matched on what each company actually does as described in its own words. Ranked by team size, largest first. Every row shows the company's own description, its RevenueBase Smart Search rating, and when it was last checked. Data refreshed September 28, 2026.

Published by RevenueBase, a B2B data infrastructure company. This list was built with RevenueBase Smart Search, 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 HQ checked on every row RevenueBase Smart Search rating on every row Refreshed Sep 28, 2026 86% judged on-target in blind review

882Companies

15,764Contacts tracked

5,401Verified emails

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The 25 largest medical device regulatory software companies based in the United States

Ranked by team size

Top 25 of 882 medical device regulatory software companies based in the United States, ranked by team size, largest first. Data refreshed Sep 28, 2026. RevenueBase Smart Search rates how each company's information relates to medical device regulatory software companies: strong evidence (its own description names it), partial (names part of it), indirect (matched on the rest of its profile rather than the description shown). Click a contact count to view that company's people.
#	Company	RevenueBase Smart Search	Headquarters	Employees	Contacts
1	Biomerics	Strong evidence	Salt Lake City, UT, United StatesHQ checked Sep 28, 2026	1,001-5,000	1,227 contacts →
	Strong evidence “Founded in 1994, Biomerics is the leading vertically integrated medical device contract manufacturer serving the interventional device market.” Source: RevenueBase Database · checked Sep 28, 2026
2	SMC LTD	Indirect evidence	Somerset, WI, United StatesHQ checked Sep 28, 2026	1,001-5,000	1,072 contacts →
	Indirect evidence Source: RevenueBase Database · checked Sep 28, 2026
3	Cirtec Medical	Strong evidence	Brooklyn Park, MN, United StatesHQ checked Sep 28, 2026	1,001-5,000	729 contacts →
	Strong evidence “Whether you’re a startup or a leading Class II or medical device manufacturer, Cirtec is here to help bring life-enhancing therapies to market – quickly and cost-effectively.” Source: RevenueBase Database · checked Sep 28, 2026
4	Valgenesis	Indirect evidence	Santa Clara, CA, United StatesHQ checked Sep 28, 2026	501-1,000	639 contacts →
	Indirect evidence “ValGenesis delivers integrated and smart solutions that support the digital transformation of the life sciences industry.” Source: RevenueBase Database · checked Sep 28, 2026
5	Aithent INC	Partial evidence	New York, NY, United StatesHQ checked Sep 28, 2026	201-500	416 contacts →
	Partial evidence “Aithent creates high-value regulatory compliance management solutions for financial services, government, healthcare and insurance organizations around the globe.” Source: RevenueBase Database · checked Sep 28, 2026
6	Harmac Medical Products	Strong evidence	Buffalo, NY, United StatesHQ checked Sep 28, 2026	1,001-5,000	308 contacts →
	Strong evidence “Your Global Partner for Full-Service Contract Manufacturing of Single-Use Medical Devices.” Source: RevenueBase Database · checked Sep 28, 2026
7	Valsource INC	Strong evidence	Downingtown, PA, United StatesHQ checked Sep 28, 2026	201-500	245 contacts →
	Strong evidence “Since 1996, ValSource has worked with hundreds of pharmaceutical, biopharma, and medical device organizations around the world.” Source: RevenueBase Database · checked Sep 28, 2026
8	MED Institute	Partial evidence	West Lafayette, IN, United StatesHQ checked Sep 28, 2026	n/a	230 contacts →
	Partial evidence “MED Institute supports consultants, manufacturers, and developers of medical products through the key phases between the start of an idea and making a product available to…” Source: RevenueBase Database · checked Sep 28, 2026
9	Mcra, An Iqvia Business	Strong evidence	Washington, DC, United StatesHQ checked Sep 28, 2026	51-200	226 contacts →
	Strong evidence “MCRA, an IQVIA business, is a leading full-service medical device, diagnostics, and biologics CRO and consulting advisory firm helping global healthcare companies maximize the…” Source: RevenueBase Database · checked Sep 28, 2026
10	Micro Systems Engineering, INC	Strong evidence	Lake Oswego, OR, United StatesHQ checked Sep 28, 2026	201-500	216 contacts →
	Strong evidence “Micro Systems Engineering, Inc.(MSEI), with its main office in Lake Oswego, Oregon, is is a pioneer in developing innovative implantable medical device technologies and devices…” Source: RevenueBase Database · checked Sep 28, 2026
11	Seisa Medical	Strong evidence	El Paso, TX, United StatesHQ checked Sep 28, 2026	1,001-5,000	216 contacts →
	Strong evidence “Seisa Group is a premier full-service medical device manufacturer.” Source: RevenueBase Database · checked Sep 28, 2026
12	QMD	Strong evidence	Cleveland, OH, United StatesHQ checked Sep 28, 2026	1,001-5,000	205 contacts →
	Strong evidence “QMD™ provides a full range of products and services to help OEMs bring medical devices to market.” Source: RevenueBase Database · checked Sep 28, 2026
13	ADM Tronics Unlimited, INC	Strong evidence	Northvale, NJ, United StatesHQ checked Sep 28, 2026	n/a	204 contacts →
	Strong evidence “ADM Tronics ("ADMT") specializes in electronic medical device design, development and manufacturing for diagnostic and therapeutic medical technologies at its FDA-Registered…” Source: RevenueBase Database · checked Sep 28, 2026
14	ECI	Partial evidence	Marlborough, MA, United StatesHQ checked Sep 28, 2026	201-500	194 contacts →
	Partial evidence “Enhanced Compliance Inc.(ECI) is a global life sciences partner delivering integrated quality, regulatory, and compliance expertise-combined with hands-on engineering execution…” Source: RevenueBase Database · checked Sep 28, 2026
15	Blue Mountain	Indirect evidence	State College, PA, United StatesHQ checked Sep 28, 2026	51-200	182 contacts →
	Indirect evidence “More uptime.” Source: RevenueBase Database · checked Sep 28, 2026
16	Gilero, A Sanner Group Company	Strong evidence	Durham, NC, United StatesHQ checked Sep 28, 2026	51-200	147 contacts →
	Strong evidence “Gilero offers end-to-end device design, development and contract manufacturing in the medical and pharmaceutical industries.” Source: RevenueBase Database · checked Sep 28, 2026
17	Advamed	Strong evidence	Washington, DC, United StatesHQ checked Sep 28, 2026	51-200	141 contacts →
	Strong evidence “Who We Are: AdvaMed's member companies produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease…” Source: RevenueBase Database · checked Sep 28, 2026
18	Greenlight Guru	Indirect evidence	Indianapolis, IN, United StatesHQ checked Sep 28, 2026	201-500	139 contacts →
	Indirect evidence “Greenlight Guru is the #1 provider of modern cloud-based QMS & EDC solutions for the MedTech industry, helping companies bring life-changing products to market faster, more…” Source: RevenueBase Database · checked Sep 28, 2026
19	Ketryx	Indirect evidence	Cambridge, MA, United StatesHQ checked Sep 28, 2026	51-200	129 contacts →
	Indirect evidence “Ketryx transforms the product lifecycle of regulated teams to deliver safer products, faster.” Source: RevenueBase Database · checked Sep 28, 2026
20	Court Square Group	Indirect evidence	Holyoke, MA, United StatesHQ checked Sep 28, 2026	51-200	123 contacts →
	Indirect evidence “Court Square Group is a leading provider of Audit Ready Compliant Cloud Infrastructure solutions for the Life Science Industry.” Source: RevenueBase Database · checked Sep 28, 2026
21	Iradimed Corporation	Strong evidence	Orlando, FL, United StatesHQ checked Sep 28, 2026	51-200	121 contacts →
	Strong evidence “IRadimed Corporation (NASDAQ: IRMD) develops, manufactures, and markets innovative MRI compatible medical devices.” Source: RevenueBase Database · checked Sep 28, 2026
22	Qualio	Indirect evidence	San Francisco, CA, United StatesHQ checked Sep 28, 2026	51-200	119 contacts →
	Indirect evidence “Qualio is a unified quality and compliance management platform that helps regulated organizations get products to market faster with reduced risk.” Source: RevenueBase Database · checked Sep 28, 2026
23	Cogmedix	Strong evidence	West Boylston, MA, United StatesHQ checked Sep 28, 2026	51-200	113 contacts →
	Strong evidence “Cogmedix provides FDA and ISO 13485 compliant product development and commercialization services to a broad range of dental and medical device innovators with unsurpassed quality…” Source: RevenueBase Database · checked Sep 28, 2026
24	Engineered Medical Systems, LLC	Strong evidence	Bartlett, TN, United StatesHQ checked Sep 28, 2026	201-500	100 contacts →
	Strong evidence “Engineered Medical Systems, LLC is a medical device manufacturing company based out of 3325 Appling Road, Bartlett, Tennessee, United States.” Source: RevenueBase Database · checked Sep 28, 2026
25	LFI	Strong evidence	Smithfield, RI, United StatesHQ checked Sep 28, 2026	51-200	92 contacts →
	Strong evidence “LFI Medical is an ISO 13485 certified, full service medical device contract manufacturer and rapid development service provider.” Source: RevenueBase Database · checked Sep 28, 2026

RevenueBase Smart Search

RevenueBase Smart Search assesses information from a company’s LinkedIn profile, information supplied directly by the company, its website, and other publicly available sources. It uses that information to rate how closely the company relates to this list’s category: medical device regulatory software companies. Every row carries its rating and the description the rating was read from, so each one can be checked rather than taken on trust.

Strong evidence: The company's own public description of its business names medical device regulatory software companies.
Partial evidence: Its own public description names part of medical device regulatory software companies, so it works in or next to the category without describing itself that way.
Indirect evidence: The description shown does not name medical device regulatory software companies. The match rests on the rest of the company's public profile rather than the one sentence quoted here, so this is the rating to check first.

RevenueBase Smart Search is how these lists are built: RevenueBase's data engine and AI assemble the companies that match a category defined in a user's own words, so a list can be about what companies actually do rather than about whichever industry code they were filed under.

Showing 25 of 882 medical device regulatory software companies based in the United States

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Medical device regulatory software companies based in the United States at a glance

As of Sep 28, 2026

34.3%Verified-email coverage

17.9Average contacts per company

1-10Median size (employees)

1.8%Largest-city concentration · Austin

Sep 28, 2026Page data refreshed

Companies by employee count

1-10

500

11-50

261

51-200

201-500

501-1,000

1,001-5,000

5,001-10,000

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 882 companies.

How this list was built

Company categories are rarely black and white. RevenueBase reads each company's own description of its business to decide whether it belongs among medical device regulatory software companies, so some rows will be adjacent to the category rather than pure plays. The description and RevenueBase Smart Search rating on every row are there so you can check each match yourself.

Source: The RevenueBase company graph: 60 million companies and 398.9 million professional contacts resolved from primary sources, queried with RevenueBase Smart Search, the natural-language company search available to every RevenueBase user.
What qualifies: Companies headquartered in the United States whose own description of what they do matches “medical device regulatory software companies”. Matching reads each company's description, not its industry code or its name.
RevenueBase Smart Search: RevenueBase Smart Search is how this list is assembled and how each row is rated. RevenueBase's data engine and AI assess a company's LinkedIn profile, information supplied directly by the company, its website and other publicly available information, then relate it to a category defined in a user's own words. Each row is rated strong evidence (its own description names medical device regulatory software companies), partial evidence (it names part of the category) or indirect evidence (the description shown names none of it and the match rests on the rest of the company's profile). The description supporting each rating is quoted on the row.
What we exclude: Companies whose own description does not clearly place them among medical device regulatory software companies, and records with no verified work email. Companies headquartered outside United States are excluded even when they keep an office there.
Match quality: In blind human judging of this matching method, 86% of matched companies were on target. Expect roughly 1 in 7 rows to be adjacent to the category rather than a pure play. Every row shows the company's own description and its RevenueBase Smart Search rating so you can judge each match yourself. Read the full methodology: how the lists are built, how the judging worked, and what the figure means.
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 listed company carries at least one verified work email, 5,401 across the full list. 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 September 28, 2026. Lists refresh periodically as the graph is re-checked.
Corrections: Wrong category, wrong headquarters, or a company that has closed? Use “Report an issue” on any row. Reports go to the RevenueBase Data Team and feed back into the company graph.

Frequently asked

What is RevenueBase Smart Search?

RevenueBase Smart Search is how RevenueBase decides which companies belong on this list and how strongly each one fits. Its data engine and AI assess a company's LinkedIn profile, information supplied directly by the company, its website and other publicly available information, then relate it to the category the list is about. Each row is rated strong evidence when the company's own description names medical device regulatory software companies, partial evidence when it names part of the category, and indirect evidence when the description shown names none of it and the match rests on the rest of the company's profile.

How many medical device regulatory software companies are there based in the United States?

RevenueBase identified 882 medical device regulatory software companies headquartered in the United States as of September 2026, matched on each company's own description of what it does rather than its industry code.

What is the largest company on this list?

Biomerics, headquartered in Salt Lake City, tops this list with the largest team on record.

Which city has the most medical device regulatory software companies?

Austin leads with 16 headquartered companies, followed by Irvine (14) and Indianapolis (13).

How do I get contact information for these companies?

A free RevenueBase account lets you run this exact search and work the top results, verified emails and direct dials included. Upgrading unlocks all 5,401 verified decision-maker contacts tracked across these 882 companies.

How current is this list?

The list refreshes periodically as the company graph is re-checked. This page's figures were pulled on September 28, 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 Smart Search, 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.