Company lists · Data refreshed September 2026
Top 25 510k submission consulting firms based in the United States
RevenueBase identified 568 510k submission consulting firms headquartered in 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 510k submission consulting firms 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 27, 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.
The 25 largest 510k submission consulting firms based in the United States
Ranked by team size| # | Company | Contacts | |||
|---|---|---|---|---|---|
| 1 | 245 contacts → | ||||
Indirect evidence “Since 1996, ValSource has worked with hundreds of pharmaceutical, biopharma, and medical device organizations around the world.” Source: RevenueBase Database · checked Sep 27, 2026Thanks. The Data Team will review it. | |||||
| 2 | 230 contacts → | ||||
Indirect 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 27, 2026Thanks. The Data Team will review it. | |||||
| 3 | 78 contacts → | ||||
Indirect evidence “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…” Source: RevenueBase Database · checked Sep 27, 2026Thanks. The Data Team will review it. | |||||
| 4 | 76 contacts → | ||||
Partial evidence “ABOUT Biologics Consulting is a complete FDA regulatory and product development consulting firm for cell & gene therapy, biologics, pharmaceuticals, and medical devices.” Source: RevenueBase Database · checked Sep 27, 2026Thanks. The Data Team will review it. | |||||
| 5 | 67 contacts → | ||||
Indirect evidence “Regulatory Compliance Associates Inc.(RCA) is a team of experienced professionals from FDA-regulated industries including pharmaceutical, biologics and medical device.” Source: RevenueBase Database · checked Sep 27, 2026Thanks. The Data Team will review it. | |||||
| 6 | 62 contacts → | ||||
Indirect evidence “Oriel STAT-A-MATRIX has joined forces with our Validant Group partners to reposition as one global regulatory brand: ELIQUENT Life Sciences.” Source: RevenueBase Database · checked Sep 27, 2026Thanks. The Data Team will review it. | |||||
| 7 | 55 contacts → | ||||
Strong evidence “At Global Regulatory Writing & Consulting (GLOBAL), we specialize in providing expert drug and device consulting, regulatory submission support, and strategic writing services.” Source: RevenueBase Database · checked Sep 27, 2026Thanks. The Data Team will review it. | |||||
| 8 | 48 contacts → | ||||
Partial evidence “SciLucent provides FDA-focused regulatory, clinical, nonclinical, CMC, quality, scientific, and management consulting services to healthcare product companies that develop…” Source: RevenueBase Database · checked Sep 27, 2026Thanks. The Data Team will review it. | |||||
| 9 | 46 contacts → | ||||
Indirect evidence “Elexes was born to help Entrepreneurs, Medical Device, Drugs and Biologics Companies meet regulatory and quality standards, overcome regulatory hurdles, stay in compliance, and…” Source: RevenueBase Database · checked Sep 27, 2026Thanks. The Data Team will review it. | |||||
| 10 | 45 contacts → | ||||
Indirect evidence “Medpoint provides medical device, diagnostic, and biopharma clients with services actively supporting domestic and international quality assurance, regulatory affairs, clinical…” Source: RevenueBase Database · checked Sep 27, 2026Thanks. The Data Team will review it. | |||||
| 11 | 40 contacts → | ||||
Indirect evidence “We specialize in Engineering, Validation, Regulatory, IT, and Non-IT related areas primarily focused on Pharmaceutical / Life Sciences and Medical devices, health care companies.” Source: RevenueBase Database · checked Sep 27, 2026Thanks. The Data Team will review it. | |||||
| 12 | 38 contacts → | ||||
Indirect evidence “MEDIcept, Inc.” Source: RevenueBase Database · checked Sep 27, 2026Thanks. The Data Team will review it. | |||||
| 13 | 34 contacts → | ||||
Indirect evidence “Pure Global unlocks global markets for medtech companies.” Source: RevenueBase Database · checked Sep 27, 2026Thanks. The Data Team will review it. | |||||
| 14 | 34 contacts → | ||||
Indirect evidence “Omnica is now part of StarFish Medical, Canada’s largest medical device design and development firm.” Source: RevenueBase Database · checked Sep 27, 2026Thanks. The Data Team will review it. | |||||
| 15 | 34 contacts → | ||||
Partial evidence “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…” Source: RevenueBase Database · checked Sep 27, 2026Thanks. The Data Team will review it. | |||||
| 16 | 33 contacts → | ||||
Partial evidence “Rook Quality Systems is a consulting firm dedicated to helping early-stage medical device companies develop and maintain effective and efficient quality systems.” Source: RevenueBase Database · checked Sep 27, 2026Thanks. The Data Team will review it. | |||||
| 17 | 32 contacts → | ||||
Indirect evidence “Thrive is a consultative solutions provider with a primary focus in the Life Sciences sector, founded in the summer of 2020.” Source: RevenueBase Database · checked Sep 27, 2026Thanks. The Data Team will review it. | |||||
| 18 | 31 contacts → | ||||
Indirect evidence “CriTech helps medical device manufacturers ensure their software is fully compliant with major medical device standards.” Source: RevenueBase Database · checked Sep 27, 2026Thanks. The Data Team will review it. | |||||
| 19 | 30 contacts → | ||||
Indirect evidence Source: RevenueBase Database · checked Sep 27, 2026Thanks. The Data Team will review it. | |||||
| 20 | 30 contacts → | ||||
Partial evidence “BioPharma Consulting JAD Group provides a complete portfolio of technical support and solutions for the FDA regulated industry.” Source: RevenueBase Database · checked Sep 27, 2026Thanks. The Data Team will review it. | |||||
| 21 | 29 contacts → | ||||
Indirect evidence “We are medical device software experts.” Source: RevenueBase Database · checked Sep 27, 2026Thanks. The Data Team will review it. | |||||
| 22 | 25 contacts → | ||||
Indirect evidence “Achieving measurable and sustainable results in healthcare is a challenging process, and having the right resources is imperative.” Source: RevenueBase Database · checked Sep 27, 2026Thanks. The Data Team will review it. | |||||
| 23 | 25 contacts → | ||||
Indirect evidence “NJK & Associates provides hands-on, action-based solutions to your Quality and Regulatory needs.” Source: RevenueBase Database · checked Sep 27, 2026Thanks. The Data Team will review it. | |||||
| 24 | 24 contacts → | ||||
Partial evidence “Kinexum is an international healthcare consulting group specializing in regulatory strategy, clinical development, and commercialization.” Source: RevenueBase Database · checked Sep 27, 2026Thanks. The Data Team will review it. | |||||
| 25 | 24 contacts → | ||||
Indirect evidence “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…” Source: RevenueBase Database · checked Sep 27, 2026Thanks. The Data Team will review it. | |||||
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: 510k submission consulting firms. 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 510k submission consulting firms.
- Partial evidence
- Its own public description names part of 510k submission consulting firms, so it works in or next to the category without describing itself that way.
- Indirect evidence
- The description shown does not name 510k submission consulting firms. 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 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, 2026Companies by employee count
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
Company categories are rarely black and white. RevenueBase reads each company's own description of its business to decide whether it belongs among 510k submission consulting firms, 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 “510k submission consulting firms”. 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 510k submission consulting firms), 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 510k submission consulting firms, 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, 1,250 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 27, 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 510k submission consulting firms, 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 510k submission consulting firms are there based in the United States?
RevenueBase identified 568 510k submission consulting firms 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?
Valsource INC, headquartered in Downingtown, tops this list with the largest team on record.
Which city has the most 510k submission consulting firms?
Minneapolis leads with 12 headquartered companies, 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 the top results, verified emails and direct dials included. Upgrading unlocks all 1,250 verified decision-maker contacts tracked across these 568 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 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 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.
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