I am looking for a regulatory consultant to help with an FDA 510(k) submission for a medical device.

• 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
• Clinical Consultants International - 11120 NE 2nd St Ste 100, Bellevue, WA 98004, United States
• Devote Consulting - 1201 3rd Ave, Seattle, WA 98101, United States
• Puget Sound Projects, Llc - 2918 2nd Ave N, Seattle, WA 98109, United States
• Ailsa Biomedical Regulatory Consulting - 2028 Purcell Way, North Vancouver, BC V7J 3K3, Canada
• Provision Consulting Group: FDA Regulatory Consulting Firm - 13925 City Center Dr Ste 200, Chino Hills, CA 91709, United States
• Ken Block Consulting LLC - 800 E Campbell Rd #202, Richardson, TX 75081, United States
• k2 regulatory consulting - 479 Cumberland Dr, Burlingame, CA 94010, United States

If you're looking in the Seattle/Puget Sound area, I found several consultants with explicit medical-device/FDA experience:

• Drug & Device Development Co — Redmond. Its public records/materials associate it with FDA regulatory strategy and 510(k) submissions.
• Gish Consulting LLC — Bellevue. Focuses on regulatory/quality support for regulated health products, including medical devices.
• Full Spectrum Quality — Seattle. Regulatory/quality consulting for life-sciences and medical-device organizations.
• Clinical Consultants International — Bellevue. Offers FDA regulatory and market-entry support, including 510(k) work.
• Smestad & Associates — a specialized medical-device regulatory/QA consultancy that explicitly lists 510(k) preparation and filing, FDA responses, risk management, and quality-system implementation.Smestad & Associates
• Regforce — specializes in 510(k) strategy and execution, including classification, predicate research, evidence planning, eSTAR preparation, FDA review, and responses to FDA questions.Regforce+1

What I'd look for in your consultant

Before hiring anyone, I'd ask for relevant experience with:

1. Your exact device category/product code, rather than just generic 510(k) experience.
2. Predicate-device selection and substantial-equivalence strategy.
3. Testing/evidence planning — including biocompatibility, electrical safety, EMC, software, cybersecurity, sterilization, usability, or clinical evidence as applicable.
4. eSTAR preparation and FDA interaction, including handling Additional Information requests.
5. QMS/design-control readiness, particularly if your design history and verification/validation documentation aren't complete.
6. Actual cleared 510(k)s they personally worked on, preferably in your device category.

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.

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.U.S. Food and Drug Administration

Some established firms that provide medical device regulatory support include:

• NAMSA — provides regulatory strategy, testing, and submission support across medical device categories.ReqoData
• Emergo by UL — supports FDA submissions, including 510(k) and global market access activities.ReqoData
• MCRA — offers regulatory and clinical consulting, including FDA pathways for medical devices.ReqoData
• Intertek — provides medical device regulatory and testing services internationally.ReqoData
• Mansour Consulting LLC — focuses on FDA, ISO 13485, UDI, and related regulatory services.Mansour Consulting

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:

1. Device description and intended use
2. FDA product code (if known)
3. Device classification (if known)
4. Predicate device(s) you are considering
5. Current development stage
6. Available testing data
7. Target submission timeline and budget

If you share:

• device type (e.g., software, implant, diagnostic, wearable, instrument),
• country of manufacture,
• whether you already have a predicate,
• and your preferred consultant location (US-only vs global),

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
• The CRO Group, Inc. - 32 Harrison St, Melrose, MA 02176, United States
• Digital Health Solutions, LLC - 10 New England Business Ctr Dr Ste 103, Andover, MA 01810, United States
• HaA Product Development - 333 North Ave 3rd Floor, Wakefield, MA 01880, United States
• Medicept - 200 Homer Ave, Ashland, MA 01721, United States
• R & C Consulting Group - 195 St Paul St, Brookline, MA 02446, United States
• Boston MedTech Advisors - 990 Washington St #204, Dedham, MA 02026, United States
• Innovative Regulatory Science Group Inc - 6 Cabot Pl #5, Stoughton, MA 02072, 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:

• o'connell regulatory consultants, inc. — North Reading, MA. Particularly interesting because its public FDA records show involvement as correspondent/applicant on multiple 510(k)s. It focuses on medical devices and combination products.FDA Access Data+1
• Rqmis — Amesbury, MA. Very convenient geographically and offers 510(k), De Novo and PMA strategy/submission support, as well as FDA meeting support and clinical/regulatory services.RQMIS
• Foresight Regulatory Strategies, Inc. — North Andover, MA. Offers FDA submission support including 510(k) and PMA; its background appears particularly relevant to ophthalmic devices.
• The CRO Group, Inc. — Melrose, MA. Provides regulatory, quality and clinical support for medical devices, IVDs, digital health/SaMD and wearables, including 510(k) submissions.
• — Worth considering if your device involves software, digital health, cybersecurity, or substantial engineering/V&V work.

My first three calls

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:

1. How many 510(k)s have you personally taken from strategy through FDA clearance?
2. Have you handled devices in my exact product code/device classification?
3. Can you identify and defend the predicate strategy?
4. Will you prepare the entire submission, or only review our team's work?
5. Who will actually work on the project, and how much FDA interaction have they personally handled?
6. Can you identify likely testing gaps—biocompatibility, EMC/electrical safety, software, cybersecurity, human factors, sterilization, etc.—before submission?
7. What happens if FDA issues an Additional Information request?
8. What is the estimated fee and timeline, and what assumptions are behind it?

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.

• 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
• Compliance 4 devices - 160 Congress Park Dr, Delray Beach, FL 33445, United States
• Medical & Regulatory Affairs Specialists, LLC - 4800 Ben Hill Trail, Lake Wales, FL 33898, United States
• Concise Engineering, Inc. - 15251 Roosevelt Blvd #209, Clearwater, FL 33760, United States
• Cosmereg LLC - 7901 4th St N Ste 4016, St. Petersburg, FL 33702, United States
• TechniReg - 19404 Pine Valley Dr, Odessa, FL 33556, United States
• FDA 510k Consultants, LLC - 1100 Del Lago Cir, Palm Beach Gardens, FL 33410, United States
• E & E Medicals and Consulting - 400 Galleria Pkwy Ste 1500, Atlanta, GA 30339, United States
• United Regulatory - 2950 W Cypress Creek Rd, Fort Lauderdale, FL 33309, 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.

Consultants worth considering

• Promedic LLC — St. Petersburg. Focuses specifically on medical-device regulatory strategy and 510(k) submissions. Its site states that it has supported 1,100+ FDA 510(k) clearances since 1992, making this one of the stronger options to interview.ProMedic, LLC.+1
• ADB Consultant & Crow — Florida-based medical-device regulatory/CRO firm. Offers 510(k) gap assessments, Pre-Subs, submission support, QMS work, clinical research, and cybersecurity. It reports 20+ years of experience and 100+ FDA submissions.ADB Consulting+2
• 510K FDA — Ormond Beach. Very specifically focused on FDA 510(k) work. FDA's own cleared 510(k) records identify 510K FDA, Inc. as the consultant/preparer on multiple submissions, which is useful evidence of actual submission experience rather than simply marketing claims.FDA Access Data+1
• — Delray Beach. A smaller firm oriented toward medical-device companies and entrepreneurs, potentially a good fit if you're a startup or first-time 510(k) sponsor.

How I'd choose

For a first-time 510(k), I would interview 2–3 consultants and ask each one:

1. How many 510(k)s have you personally taken from strategy through FDA clearance?
2. Have you worked with my specific device type, FDA product code, and review panel?
3. What predicates would you initially consider, and why?
4. Will you prepare the complete submission/eSTAR, or only advise my team?
5. What testing gaps do you anticipate—biocompatibility, electrical safety/EMC, software, cybersecurity, sterilization, packaging, usability, etc.?
6. How do you handle FDA Additional Information (AI) requests after submission?
7. Can you provide examples of recently cleared devices they've worked on?
8. Is the engagement fixed-fee, hourly, or milestone-based?

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.