I am looking for a regulatory consultant to help with an FDA 510(k) submission for a medical device.
Data as of Sep 21, 2026 · Based on 290 AI responses from ChatGPT Search and Google AI Mode · See how Parse measures this
Data as of Sep 21, 2026 · Based on 290 AI responses from ChatGPT Search and Google AI Mode · See how Parse measures this
Multiple reputable regulatory firms support FDA 510(k) submissions. 
Brands AI recommends here
Named in 56% of answers
Best for large programs requiring extensive clinical and regulatory strategy. They manage a high volume of pre-submission meetings and support complex Class II and IVD medical devices.
Named in 56% of answers
Best for end-to-end global support. They provide gap analysis, device classification, and act as an official U.S. Agent for foreign businesses during the FDA submission process.
Named in 50% of answers
Best for reducing the risk of FDA rejection. Utilizing a team of former FDA reviewers, they focus on rapid readiness reviews and future-proof regulatory guidance to ensure submissions are compliant.
Named in 50% of answers
Source | Citation share |
|---|---|
FDA 510(k) Consulting for Medical Device Compliance | Emergo by ULhttps://www.emergobyul.com/services/us-fda-510k-consulting-medical-devices-and-ivds | 5% |
FDA 510(k) Consulting Services | The FDA Grouphttps://www.thefdagroup.com/services/510k | 5% |
 FDA 510(k) Consultinghttps://www.intertek.com/consulting/medical/fda-510k/ | 3% |
 FDA Regulatory Consultant For Medical Devices | MCRAhttps://www.mcra.com/services/fda-regulatory-consultant | 3% |
Medical Device and IVD FDA 510(k) Clearance Consultantshttps://namsa.com/services/consulting/us-fda/fda-510k-consultants/ | 3% |
 Find Vetted FDA 510(k) Consultants - Cruxihttps://cruxi.ai/pages/regulatory/fda-510k-consultant.html | 3% |
 FDA 510k Consulting Serviceshttps://atslab.com/specialty/medical-device-components/fda-510k-consulting-services/ | 3% |
US FDA Consulting for Medical Device and IVD Manufacturershttps://namsa.com/services/consulting/us-fda/ | 2% |
 FDA Consultantshttps://fdaconsultants.com/ | 2% |
 FDA 510(k) Consulting, FDA 510(k) Consultant - FDA 510k Consultinghttps://www.fda510kconsultant.com/about-us.php | 2% |
Finding the right regulatory consultant for an FDA 510(k) submission can significantly streamline your path to clearance. Depending on whether you are a startup needing end-to-end guidance or an established manufacturer looking for niche predicate and testing support, several well-regarded firms specialize in this…
Finding the right regulatory consultant for an FDA 510(k) submission can significantly streamline your path to clearance. Depending on whether you are a startup needing end-to-end guidance or an established manufacturer looking for niche predicate and testing support, several well-regarded firms specialize in this area.
To help me narrow down the best specific recommendations or resources for your project, please let me know:
- **Drug & Device Development Co** - 15600 Redmond Wy #205, Redmond, WA 98052, United States - **Gish Consulting LLC** - 12400 SE 38th St #52753, Bellevue, WA 98006, United States - **Full Spectrum Quality** - 14419 Greenwood Ave N, Seattle, WA 98133, United States
If you're looking in the Seattle/Puget Sound area, I found several consultants with explicit medical-device/FDA experience:
Before hiring anyone, I'd ask for relevant experience with:
One important point: don't assume that because a consultant says they "do 510(k)s" they're necessarily the right fit. The regulatory strategy can depend heavily on the device's intended use, technology, classification, product code, and available predicate.
If you tell me what the device does, whether it's hardware/software/diagnostic, your intended use, and roughly where you are in development, I can narrow this to a few consultants that appear particularly relevant and compare their stated capabilities.
Finding the right regulatory consultant for an **FDA 510(k)** submission can significantly streamline your path to market clearance. Several reputable firms and specialized directories offer expert guidance on predicate research, testing requirements, and agency…
Finding the right regulatory consultant for an FDA 510(k) submission can significantly streamline your path to market clearance. Several reputable firms and specialized directories offer expert guidance on predicate research, testing requirements, and agency interactions:
To help me narrow down the best type of consultant or firm for your specific needs, could you share:
I can help you identify and vet FDA 510(k) regulatory consultants. A good consultant can help with device classification, predicate strategy, testing plans, submission preparation, FDA interactions, and responses to additional information requests. A 510(k) submission generally needs to demonstrate substantial…
I can help you identify and vet FDA 510(k) regulatory consultants. A good consultant can help with device classification, predicate strategy, testing plans, submission preparation, FDA interactions, and responses to additional information requests. A 510(k) submission generally needs to demonstrate substantial equivalence to a legally marketed predicate device and may include items such as performance testing, labeling, software documentation, biocompatibility, sterilization, and EMC/electrical safety evidence depending on the device.
Some established firms that provide medical device regulatory support include:
When selecting a consultant, I would screen for:
Device-specific 510(k) experience
Ask for examples of cleared devices in your product category (e.g., orthopedic, software as a medical device, diagnostics, cardiovascular, dental).
Predicate strategy experience
A consultant should be able to justify the proposed predicate and identify potential FDA review risks.
Testing strategy capability
They should understand what evidence is likely needed before submission rather than discovering gaps after filing.
FDA interaction experience
Experience preparing pre-submission (Q-Submission) questions, responding to FDA requests, and managing review cycles can be valuable.
Quality system knowledge
Confirm familiarity with design controls, risk management, and current FDA quality requirements.
Before hiring, prepare a short brief containing:
If you share:
I can help narrow this to consultants with the most relevant experience.
- **o'connell regulatory consultants, inc.** - 5 Timber Ln, North Reading, MA 01864, United States - **Rqmis** - 110 Haverhill Rd, Amesbury, MA 01913, United States - **Foresight Regulatory Strategies, Inc.** - 1820 Turnpike St #201, North Andover, MA 01845, United States
If you're in the Haverhill/North Shore area, there are several promising options for an FDA 510(k). I’d shortlist these:
For a straightforward Class II 510(k), I'd start with O'Connell Regulatory Consultants, RQMIS, and QA Consulting. For a software/AI/digital-health device, I'd move Digital Health Solutions or The CRO Group higher on the list.
When interviewing consultants, I'd specifically ask:
If you tell me what the device does, its intended use, whether it's hardware/software/implantable/etc., and whether you already have a likely predicate, I can narrow this to 3–5 consultants that are specifically suited to your device rather than just general 510(k) firms.
Finding the right regulatory consultant for an FDA 510(k) submission can make a major difference in avoiding costly delays and ensuring your device demonstrates **substantial equivalence** correctly.[](https://www.elexes.com/feeds/blog/best-510k-consultants-united-states)…
Finding the right regulatory consultant for an FDA 510(k) submission can make a major difference in avoiding costly delays and ensuring your device demonstrates substantial equivalence correctly.
Here is a breakdown of prominent consulting options, what to look for, and how to approach the selection process:
To help me point you toward the most relevant type of consultant or firm, could you share:
- **Promedic LLC** - 131 Bay Point Dr NE, St. Petersburg, FL 33704, United States - **ADB Consultant & Crow** - 3120 W 84th St, Hialeah, FL 33018, United States - **510K FDA** - 156 E Granada Blvd, Ormond Beach, FL 32176, United States
Yes. I searched for firms with demonstrated medical-device/FDA 510(k) experience, with an emphasis on Florida since you appear to be in the Winter Haven area.
For a first-time 510(k), I would interview 2–3 consultants and ask each one:
One important point: the right consultant depends heavily on the device. A consultant who is excellent with orthopedic implants may not be the best choice for an SaMD/AI device, diagnostic, dental device, electromechanical device, etc.
If you tell me (a) what the medical device does, (b) whether it is hardware/software/combination, (c) whether you already have a likely predicate, and (d) whether you're a startup or established manufacturer, I can narrow this to 3–5 consultants that specifically match your device and compare their experience, location, services, and contact information.
Navigating an FDA 510(k) submission requires specialized regulatory strategy, rigorous testing data documentation, and a clear understanding of predicate devices.[](https://namsa.com/services/consulting/us-fda/fda-510k-consultants/) [[1]](https://namsa.com/services/consulting/us-fda/fda-510k-consultants/) A selection…
Navigating an FDA 510(k) submission requires specialized regulatory strategy, rigorous testing data documentation, and a clear understanding of predicate devices.
A selection of reputable medical device regulatory consulting firms and groups that specialize in 510(k) submissions include:
To help me narrow down the best recommendation or outline a precise path forward, could you tell me:
Top regulatory consulting firms for an FDA 510(k) submission include The FDA Group, [NAMSA](https://namsa.com/services/consulting/us-fda/fda-510k-consultants/) , and [Elexes](https://www.elexes.com/) , all of which feature former FDA reviewers and high approval success…
Top regulatory consulting firms for an FDA 510(k) submission include The FDA Group, NAMSA , and Elexes , all of which feature former FDA reviewers and high approval success rates.
Could you tell me:
I can help narrow down which consultant or firm fits your specific device category best.
- **Keystone Regulatory Services, LLC** - 342 E Main St #207, Leola, PA 17540, United States - **Smith Associates** - Crofton, MD 21114 - **ACMD Consulting** - 2600 Mullinix Mill Rd, Mt Airy, MD 21771, United States
I can help you identify a regulatory consultant for an FDA 510(k) submission. The best fit depends heavily on your device type (e.g., software as a medical device, implant, diagnostic, cardiovascular, dental, etc.), risk class, and where you are in development.
A few consultants/firms with 510(k) experience to consider:
When selecting a consultant, I would ask for:
FDA’s current 510(k) process centers on demonstrating substantial equivalence to a legally marketed predicate device, and submissions are generally prepared using the FDA’s eSTAR electronic submission template.
If you tell me:
I can narrow this to a shorter list of consultants that match your situation.
