FDA Regulatory Experts

What FDA Regulatory Experts does

FDA Regulatory Experts, doing business as One Way Consultants, LLC, is an independent FDA regulatory consulting firm founded in 2011 and based in Rosewood Heights, Illinois. The firm specializes in regulatory affairs, quality systems, and clinical study support for medical device manufacturers across Class I, II, and III devices, with service offerings spanning mock FDA inspections, FDA-483 and Warning Letter responses, 510(k) Premarket Notifications, IDE, De Novo, and PMA submissions, GMP and design control (21 CFR Part 820.30) training and audits, clinical study design and management, FDA pre-submission meeting preparation, CAPA program evaluation, and expert witness testimony.

The firm's delivery model is principal-consultant led: Larry Stevens, who combines 20+ years of FDA experience with 18 years as a medical device industry senior executive, personally leads engagements and draws on a screened network of independent quality and regulatory consultants (specializing in FDAAA, QA/QC, and QR) for capacity overflow. This positioning, supported by Stevens' prior service on the FDA Circulatory Systems panel (1989-1993) and 250+ public presentations, is the firm's central differentiator against larger regulatory consultancies.

The business model is professional services on a quote-based, hourly or per-project billing structure, with a free initial consultation and a public guarantee of "FDA success." Go-to-market is sales-led and community-led: direct phone/email outreach supplemented by an educational blog ("FDA and Devices"), regular webinars, an active LinkedIn presence, and word-of-mouth referrals within the medical device and legal communities. The firm holds no external investment, has no patents or awards, and operates exclusively within the United States.

Name

FDA Regulatory Experts

Legal name

One Way Consultants, LLC

Website

https://fdadeviceexpert.com

Company type

Private

Founded year

2011

Operating status

Operating

Headcount range

1–10 employees

Short description

FDA Regulatory Experts (One Way Consultants, LLC) is an independent consulting firm providing FDA regulatory, quality systems, and clinical study services to Class I-III medical device manufacturers, led by Principal Consultant Larry Stevens and supported by vetted partner consultants.

Ownership category

akta.pro rank

Product category

Regulatory Affairs Consulting

NAICS

Management, Scientific, and Technical Consulting Services (5416)

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Regulatory Operations & Publishing (eCTD, RIM, Submission Management) (HLAGAKAC)

akta.pro secondary industry

Medical Device Regulators (HLAJADAC)

Keywords

• FDA regulatory consulting
• Medical device compliance
• FDA submission services
• Quality system consulting
• Regulatory affairs advisory

Headquarters

HQ city

East Alton

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Marketing or Sales, Operations, Others

Revenue model

1. Regulatory Consulting Services: Professional consulting services for FDA regulatory compliance, including mock FDA inspections, FDA-483 responses, Warning Letter responses, 510(k) submissions, IDE, PMA applications, design controls, and clinical trial management. Billed hourly or by project engagement.
2. Expert Witness Services: Serves as expert witness for cases involving FDA regulation compliance for medical devices.

Pricing tiers

Go-to-market motion2 records

Distribution channels1 record

Marketing channels4 records

Core offering

FDA Regulatory Experts, operated by One Way Consultants LLC, provides specialized FDA regulatory consulting services for medical device companies. The firm delivers quality systems services (mock inspections, FDA-483 and Warning Letter responses), regulatory submission services (510(k), IDE, De Novo, PMA), FDA compliance training programs, design control consulting per 21 CFR Part 820.30, and clinical study design and management. Expert witness services for FDA-related litigation are also offered.

Product overview

FDA Regulatory Experts, operated by One Way Consultants LLC, is a consulting advisory firm providing specialized FDA regulatory consulting services for the medical device industry. The company offers a comprehensive suite of regulatory affairs, quality assurance, and compliance services organized into five primary service categories: (1) Quality Systems services including mock FDA inspections, FDA-483 and Warning Letter responses; (2) Regulatory Submissions services covering 510(k), IDE, De Novo, and PMA applications; (3) FDA Training programs including GMP, regulatory submissions, internal auditor, labeling/advertising, and train-the-trainer; (4) Design Control services per 21 CFR Part 820.30; (5) Clinical Study Design and Management services; and (6) FDA Pre-Submission Meeting support. Additional offerings include expert witness services and CAPA program evaluation. The firm does not offer a software platform or technology product—it delivers professional consulting services through expert personnel.

Differentiator

Problem solved

Functional benefit

Products and services

• Mock FDA Inspections Pre-inspection readiness assessments that simulate FDA facility audits to identify compliance gaps before actual regulatory inspections occur. For medical device manufacturers.
• FDA-483 Responses Expert assistance in preparing and formulating responses to FDA Form 483 observations issued during regulatory inspections. For medical device manufacturers.
• FDA Warning Letter Responses Strategic planning and response development for FDA Warning Letters, including corrective action plans and remediation strategies. For medical device manufacturers.
• 510(k) Premarket Notification Preparation and submission of 510(k) premarket notifications to FDA demonstrating substantial equivalence for Class I, II, and certain Class III medical devices. For medical device manufacturers.
• IDE - Investigational Device Exemption Regulatory submission services for Investigational Device Exemption applications required to conduct clinical trials on unapproved devices. For medical device manufacturers.
• De Novo Application Preparation and submission of De Novo requests for novel medical devices without a predicate that require a new classification category. For medical device manufacturers.
• Premarket Approval Application (PMA) Comprehensive PMA preparation and submission services for Class III medical devices requiring FDA approval based on safety and effectiveness data. For medical device manufacturers.
• GMP Training Good Manufacturing Practice training programs covering FDA quality system requirements under 21 CFR Part 820. For medical device manufacturer personnel.
• Regulatory Submissions Training Professional development training on FDA regulatory submission processes, documentation requirements, and strategic planning. For medical device regulatory personnel.
• Internal Auditor Training Training programs for internal quality auditors to conduct effective quality system audits per FDA requirements. For medical device quality personnel.
• FDA Labeling and Advertising Training Training on FDA labeling requirements, promotional claims, and advertising compliance for medical devices. For medical device marketing and regulatory staff.
• Train the Trainers Program Comprehensive train-the-trainer program enabling organizations to develop internal FDA compliance training capabilities. For medical device manufacturers.
• Design Control Consulting (21 CFR Part 820.30) Assistance in establishing and maintaining design control procedures per FDA requirements, including design input, output, verification, validation, and design review. For medical device manufacturers.
• Mock FDA Design Control Audit Simulated FDA design control audits to assess compliance with 21 CFR Part 820.30 requirements. For medical device manufacturers.
• Clinical Study Design and Management Comprehensive clinical trial services including establishing endpoints, creating protocols, informed consent documents, IRB approval, and FDA IDE submissions. For medical device manufacturers.
• FDA Pre-Submission Meeting Support Arrangement and management of FDA pre-submission meetings including contact, meeting request preparation, and meeting conduct services. For medical device manufacturers.
• Expert Witness Services Expert witness services for legal cases involving FDA regulation compliance for medical devices. For attorneys and law firms.
• CAPA Program Evaluation Assessment of Corrective and Preventive Action programs to ensure effectiveness and FDA compliance. For medical device manufacturers.
• FDA Strategic Plans Development of strategic regulatory plans for startup companies navigating FDA approval pathways. For medical device startups and manufacturers.

Quantifiable outcome

• Guaranteed FDA success or problems solved

Named customers1 record

Segments2 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Partnerships

One partnership is on record.

• Independent Quality and Regulatory ConsultantsminorOthersThe company partners with independent quality and regulatory experts who have been screened and vetted. Partners are described as qualified and successful consultants. The partner network includes specialists in FDAAA, QA/QC, and QR areas. However, specific partner company names are not disclosed on the website.

Scale indicators4 records

Recent moves4 records

Expansion highlights4 records

Direct peers

• Innolitics: Medical device software and regulatory consulting firm supporting FDA submissions, cybersecurity, and SaMD compliance. Comparable as a niche, expertise-led regulatory consultancy for medical device software developers.
• StarFish Medical: Medical device product development and regulatory consulting firm with FDA submission expertise. Comparable in supporting medtech innovators through design controls, clinical, and regulatory pathways.
• ProPharma Group: Life sciences consulting firm providing regulatory affairs, pharmacovigilance, and compliance services to pharma and medical device companies. Comparable in service lines (regulatory submissions, quality systems) and target customer profile.
• Celegence: Regulatory affairs and compliance consulting firm supporting medical device and pharmaceutical companies with submissions, gap analyses, and remediation. Comparable boutique peer in regulatory services for regulated life sciences clients.
• The FDA Group: Specialized FDA regulatory and quality consulting firm serving pharmaceutical and medical device manufacturers with inspection readiness, submissions, and remediation support. Most directly comparable boutique peer to FDA Regulatory Experts in scope and target client profile.

Broad incumbents

• NAMSA: Large medical device-focused CRO offering regulatory, clinical, and laboratory testing services across the full product lifecycle. Comparable as a full-service regulatory/quality partner to medical device manufacturers, though at materially larger scale.
• IQVIA: Global CRO and life sciences consulting firm with broad regulatory affairs and clinical capabilities. Overlaps with FDA Regulatory Experts' regulatory submission and clinical study services, but at very different scale and geographic reach.

Emerging players

• Greenlight Guru: Medical device quality management system (QMS) software platform with adjacent consulting and training services. Comparable at the intersection of regulatory/quality enablement for medtech, though it sells a software platform rather than pure consulting.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat3 records

Key risks6 records

Key highlights6 records

Customer concentration

• Facebookfacebook.com/FDAexpert
• LinkedInlinkedin.com/company/one-way-consultants-llc-fda-regulatory-experts

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about FDA Regulatory Experts