Company lists · Data refreshed September 2026

Top 25 510k submission consulting firms based in the United States

RevenueBase identified 568 company matches for 510k submission consulting firms associated with the United States as of September 2026 and tracks 3,770 professional contacts across them, including 1,250 with verified work emails. Minneapolis is the largest hub.

This list covers company matches for 510k submission consulting firms 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 September 27, 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 Sep 27, 2026 How this list was built
568Companies
3,770Contacts tracked
1,250Verified emails
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The 25 largest 510k submission consulting firms based in the United States

Ranked by team size
Top 25 of 568 company matches for 510k submission consulting firms based in the United States, ordered by professional contacts tracked in RevenueBase, largest first. Recorded Sep 27, 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 matchDowningtown, PA, United StatesHQ recorded Sep 27, 2026201-500245 contacts →

Exact match

“Since 1996, ValSource has worked with hundreds of pharmaceutical, biopharma, and medical device organizations around the world.”

Recorded in the RevenueBase company graph · Sep 27, 2026 · View company records in RevenueBase
2Exact matchWest Lafayette, IN, United StatesHQ recorded Sep 27, 2026n/a230 contacts →

Exact match

“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…”

Recorded in the RevenueBase company graph · Sep 27, 2026 · View company records in RevenueBase
3Exact matchTolland, CT, United StatesHQ recorded Sep 27, 202611-5078 contacts →

Exact match

“WHAT WE DO: We’ve spent the past 60 years as a trusted research partner, medical device regulatory compliance, IP advisory and risk mitigation expert for the biggest brands and…”

Recorded in the RevenueBase company graph · Sep 27, 2026 · View company records in RevenueBase
4Exact matchAlexandria, VA, United StatesHQ recorded Sep 27, 202651-20076 contacts →

Exact match

“ABOUT Biologics Consulting is a complete FDA regulatory and product development consulting firm for cell & gene therapy, biologics, pharmaceuticals, and medical devices.”

Recorded in the RevenueBase company graph · Sep 27, 2026 · View company records in RevenueBase
5Exact matchPleasant Prairie, WI, United StatesHQ recorded Sep 27, 202651-20067 contacts →

Exact match

“Regulatory Compliance Associates Inc.(RCA) is a team of experienced professionals from FDA-regulated industries including pharmaceutical, biologics and medical device.”

Recorded in the RevenueBase company graph · Sep 27, 2026 · View company records in RevenueBase
6Exact matchWashington, DC, United StatesHQ recorded Sep 27, 202611-5062 contacts →

Exact match

“Oriel STAT-A-MATRIX has joined forces with our Validant Group partners to reposition as one global regulatory brand: ELIQUENT Life Sciences.”

Recorded in the RevenueBase company graph · Sep 27, 2026 · View company records in RevenueBase
7Exact matchTukwila, WA, United StatesHQ recorded Sep 27, 202651-20055 contacts →

Exact match

“At Global Regulatory Writing & Consulting (GLOBAL), we specialize in providing expert drug and device consulting, regulatory submission support, and strategic writing services.”

Recorded in the RevenueBase company graph · Sep 27, 2026 · View company records in RevenueBase
8Exact matchFairfax, VA, United StatesHQ recorded Sep 27, 202611-5048 contacts →

Exact match

“SciLucent provides FDA-focused regulatory, clinical, nonclinical, CMC, quality, scientific, and management consulting services to healthcare product companies that develop…”

Recorded in the RevenueBase company graph · Sep 27, 2026 · View company records in RevenueBase
9Exact matchSheridan, WY, United StatesHQ recorded Sep 27, 202611-5046 contacts →

Exact match

“Elexes was born to help Entrepreneurs, Medical Device, Drugs and Biologics Companies meet regulatory and quality standards, overcome regulatory hurdles, stay in compliance, and…”

Recorded in the RevenueBase company graph · Sep 27, 2026 · View company records in RevenueBase
10Exact matchGreenville, SC, United StatesHQ recorded Sep 27, 202611-5045 contacts →

Exact match

“Medpoint provides medical device, diagnostic, and biopharma clients with services actively supporting domestic and international quality assurance, regulatory affairs, clinical…”

Recorded in the RevenueBase company graph · Sep 27, 2026 · View company records in RevenueBase
11Exact matchSan Diego, CA, United StatesHQ recorded Sep 27, 202611-5040 contacts →

Exact match

“We specialize in Engineering, Validation, Regulatory, IT, and Non-IT related areas primarily focused on Pharmaceutical / Life Sciences and Medical devices, health care companies.”

Recorded in the RevenueBase company graph · Sep 27, 2026 · View company records in RevenueBase
12Exact matchBoston, NC, United StatesHQ recorded Sep 27, 202611-5038 contacts →

Exact match

“MEDIcept, Inc.”

Recorded in the RevenueBase company graph · Sep 27, 2026 · View company records in RevenueBase
13Exact matchJersey City, NJ, United StatesHQ recorded Sep 27, 202651-20034 contacts →

Exact match

“Pure Global unlocks global markets for medtech companies.”

Recorded in the RevenueBase company graph · Sep 27, 2026 · View company records in RevenueBase
14Exact matchIrvine, CA, United StatesHQ recorded Sep 27, 202611-5034 contacts →

Exact match

“Omnica is now part of StarFish Medical, Canada’s largest medical device design and development firm.”

Recorded in the RevenueBase company graph · Sep 27, 2026 · View company records in RevenueBase
15Exact matchNew York * Toronto * Florida, FL, United StatesHQ recorded Sep 27, 202611-5034 contacts →

Exact match

“MIDI is an award-winning strategic turnkey, FDA, and ISO compliant product development consulting firm with over 50 years of experience servicing domestic and international…”

Recorded in the RevenueBase company graph · Sep 27, 2026 · View company records in RevenueBase
16Exact matchAtlanta, GA, United StatesHQ recorded Sep 27, 202611-5033 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 · Sep 27, 2026 · View company records in RevenueBase
17Exact matchWoburn, MA, United StatesHQ recorded Sep 27, 202611-5032 contacts →

Exact match

“Thrive is a consultative solutions provider with a primary focus in the Life Sciences sector, founded in the summer of 2020.”

Recorded in the RevenueBase company graph · Sep 27, 2026 · View company records in RevenueBase
18Exact matchSaline, MI, United StatesHQ recorded Sep 27, 202651-20031 contacts →

Exact match

“CriTech helps medical device manufacturers ensure their software is fully compliant with major medical device standards.”

Recorded in the RevenueBase company graph · Sep 27, 2026 · View company records in RevenueBase
19Exact matchSummit, NJ, United StatesHQ recorded Sep 27, 202611-5030 contacts →

Exact match

Recorded description not available.

Recorded in the RevenueBase company graph · Sep 27, 2026 · View company records in RevenueBase
20Exact matchCambridge, MA, United StatesHQ recorded Sep 27, 202651-20030 contacts →

Exact match

“BioPharma Consulting JAD Group provides a complete portfolio of technical support and solutions for the FDA regulated industry.”

Recorded in the RevenueBase company graph · Sep 27, 2026 · View company records in RevenueBase
21Exact matchAustin, TX, United StatesHQ recorded Sep 27, 202611-5029 contacts →

Exact match

“We are medical device software experts.”

Recorded in the RevenueBase company graph · Sep 27, 2026 · View company records in RevenueBase
22Exact matchDayton, OH, United StatesHQ recorded Sep 27, 202611-5025 contacts →

Exact match

“Achieving measurable and sustainable results in healthcare is a challenging process, and having the right resources is imperative.”

Recorded in the RevenueBase company graph · Sep 27, 2026 · View company records in RevenueBase
23Exact matchSan Diego, CA, United StatesHQ recorded Sep 27, 20261-1025 contacts →

Exact match

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

Recorded in the RevenueBase company graph · Sep 27, 2026 · View company records in RevenueBase
24Exact matchHarpers Ferry, WV, United StatesHQ recorded Sep 27, 202611-5024 contacts →

Exact match

“Kinexum is an international healthcare consulting group specializing in regulatory strategy, clinical development, and commercialization.”

Recorded in the RevenueBase company graph · Sep 27, 2026 · View company records in RevenueBase
25Exact matchSt. Paul, MN, United StatesHQ recorded Sep 27, 202611-5024 contacts →

Exact match

“Blue Sages has over 20 years of experience working with the world’s best and most admired Medical Device companies creating state-of-the-art products and systems that get to…”

Recorded in the RevenueBase company graph · Sep 27, 2026 · View company records in RevenueBase

Showing 25 of 568 510k submission consulting firms based in the United States

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510k submission consulting firms based in the United States at a glance

As of Sep 27, 2026
33.2%Verified-email coverage
6.6Average contacts per company
1-10Median size (employees)
2.1%Largest-city concentration · Minneapolis
Sep 27, 2026Page data refreshed

Companies by employee count

1-10
424
11-50
112
51-200
29
201-500
1
501-1,000
2

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 568 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 “510k submission consulting firms” 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 1,250 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 September 27, 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 “510k submission consulting firms”; each Exact match badge shows search membership, not an individual similarity or quality score.

How many 510k submission consulting firms are there based in the United States?

RevenueBase identified 568 company matches for 510k submission consulting firms associated with the United States as of September 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?

Valsource INC tops the displayed preview by professional contacts tracked in RevenueBase. Recorded headquarters appear in the company rows.

Which city has the most 510k submission consulting firms?

Minneapolis leads with 12 company records, followed by San Diego (12) and Irvine (11).

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 1,250 professional contacts with verified work emails tracked across these 568 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 September 27, 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.