What mdi Consultants does

mdi Consultants is a privately held regulatory compliance consulting firm founded in 1978 by former FDA investigator Alan Schwartz and headquartered in Great Neck, New York. The firm guides medical device, pharmaceutical, biologic, food, dietary supplement, and cosmetic manufacturers through FDA, EU (CE Mark), Health Canada, and international regulatory requirements. Core services include 510(k) premarket submissions, FDA establishment registration, U.S. Agent representation for foreign manufacturers, ISO 13485/9001 and MDSAP certification, CE Mark consulting, risk analysis under ANSI/AAMI/ISO 14971, and emergency crisis intervention for FDA enforcement actions including 483 responses and warning letters.

The firm operates on a fixed-price service model rather than hourly billing, offering outcome guarantees that include 510(k) clearance and 100% first-time ISO certification when clients follow its prescribed process. Its intellectual property comprises proprietary quality management system manuals, validation protocols, technical files, and audit methodologies developed over 45 years of practice. The portfolio has expanded into cybersecurity (Software Penetration Validation under FD&C Act section 524B, launched April 2024), Lab-Developed Tests compliance, and the 510(k) Marketplace for clearance transfers. Typical 510(k) consulting engagements are priced between $15,000 and $80,000+ depending on device complexity, with engagement-driven revenue complemented by subscription-style training and retainer relationships.

mdi Consultants serves a globally diversified client base across 40+ countries from its headquarters and 10 international representative offices in Charlotte, Knoxville, Los Angeles, France, Germany, South Korea, China, Pakistan, and India. The firm claims over 1,800 successful 510(k) applications, more than 1,000 CE marks, 400+ quality systems implemented, and 35+ retainer accounts (12 of which exceed 10 years in tenure), and it lists Boston Scientific, Johnson & Johnson, Pfizer, Becton Dickinson, and Fujifilm among its enterprise clients. Leadership comprises founder Alan Schwartz (President/Founder) and Dr. Anand Akerkar (President and CEO), supported by a team with 200+ years of cumulative industry experience and 13-year average tenure.

Name

mdi Consultants

Legal name

mdi Consultants, Inc.

Website

https://mdiconsultants.com

Company type

Private

Founded year

1978

Operating status

Operating

Headcount range

11–50 employees

Short description

mdi Consultants is a privately held FDA regulatory compliance consulting firm, founded in 1978 and based in Great Neck, NY, that helps medical device, pharmaceutical, and food companies secure FDA 510(k) clearances, CE Marks, ISO certifications, and U.S. Agent representation across 40+ countries.

Ownership category

akta.pro rank

Product category

Healthcare Regulatory Compliance Consulting

NAICS

Management Consulting Services (54161)

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Clinical Quality Assurance (GCP QA, TMF/QMS oversight) (HLAGAKAI)

Keywords

• FDA regulatory consulting
• 510(k) submissions
• Medical device compliance
• Pharmaceutical regulatory affairs
• ISO certification services

Headquarters

HQ city

Great Neck

HQ country

United States

HQ region

North America

Offices10 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Marketing or Sales, Technology or R&D

Revenue model

1. Regulatory Consulting Services: Professional consulting services for FDA, EU, and international regulatory compliance. Services include 510(k) submissions, CE Mark, Health Canada licensing, ISO certification, quality system implementation, and FDA inspection support. Fixed-price engagements with no hourly billing.
2. Retainer Accounts: Ongoing consulting relationships with retainer clients. Over 35 retainer accounts with 12 accounts lasting over 10 years. Provides recurring revenue through established client relationships.
3. US Agent Services: Designated US Agent services for foreign medical device, pharmaceutical, and biological manufacturers as required by FDA regulations.
4. Training Services: FDA cGMP employee training, internal auditor training, and regulatory compliance training programs.

Pricing tiers

Go-to-market motion2 records

Distribution channels3 records

Marketing channels5 records

Core offering

mdi Consultants provides fixed-price FDA regulatory compliance consulting services to medical device, pharmaceutical, biologics, generic drug, food, beverage, dietary supplement, and cosmetic companies. Core services include preparation and management of FDA 510(k) premarket submissions, FDA establishment registrations, US Agent representation for foreign manufacturers, CE Mark certification, Health Canada licensing, ISO 13485/9001 implementation, risk analysis, and crisis intervention for FDA enforcement situations. The firm operates on a guaranteed outcomes model with 510(k) clearance and first-time ISO certification guarantees.

Product overview

mdi Consultants is a regulatory consulting firm offering a comprehensive portfolio of FDA regulatory compliance services. The core offering centers on FDA 510(k) premarket submissions, FDA registrations, and U.S. Agent representation services. The company provides supporting services including ISO compliance, risk analysis, crisis intervention, and specialized consulting for in vitro diagnostics, medical device reimbursement, and food industry compliance. A notable new service is Software Penetration Validation for cybersecurity compliance. The service model operates on a fixed-price basis with guarantees for 510(k) clearance and ISO certification outcomes.

Differentiator

Problem solved

Functional benefit

Products and services

• FDA 510(k) Consulting Expert guidance through the FDA 510(k) premarket notification process, demonstrating substantial equivalence to predicate devices for Class II medical devices. Includes preparation of all 21 submission sections and management of all FDA correspondence through clearance.
• FDA Registrations Assistance with U.S. FDA establishment registration and compliance for foreign and domestic companies manufacturing medical devices, pharmaceuticals, and food products.
• U.S. Agent Services

Quantifiable outcome

• 100% first-time ISO certification pass rate
• +5 more outcomes

Named customers20 records

Segments5 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Two partnerships are on record, tiered core and supporting.

• Crown Mutual Medical Group (CMG)coreStrategic or Co-development Partner · 1 July 2022CMG, a Canadian-based medical supply manufacturer, supply chain management services provider, and fully integrated services provider, partnered with mdi Consultants for global regulatory services including FDA, Health Canada, and other jurisdictions. CMG is headquartered in Vancouver, British Columbia with manufacturing facilities in Delta, BC and global offices in Toronto, Las Vegas, and Shenzhen.
• Kinectrics.comsupportingOthersCMG partnered with Kinectrics.com for ASTM product certifications as part of their integrated certification and consulting services offering alongside mdi Consultants for regulatory services.

Scale indicators12 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Registrar Corp: Registrar Corp provides FDA compliance services, US Agent representation, and registration support for medical device, drug, and food companies — a direct, similarly-sized competitor to mdi in regulatory and US Agent services.
• EAS Consulting Group: EAS Consulting Group provides FDA regulatory and quality consulting across food, dietary supplements, cosmetics, and pharmaceuticals — directly comparable in service mix (FDA compliance, HACCP, labeling) and customer base.
• Regulatory Compliance Associates (RCA): RCA specializes in regulatory affairs, quality compliance, and validation services for the medical device and pharmaceutical industries, closely overlapping mdi's medical-device regulatory practice.
• Greenleaf Health: Greenleaf Health provides FDA regulatory strategy and policy consulting for drug, device, and biologic companies — a directly comparable boutique firm with similar regulatory affairs focus and former-FDA talent.
• FDAImports.com: FDAImports.com offers US Agent services, FDA registration, and import compliance support for foreign manufacturers — a direct competitor for mdi's US Agent and foreign-manufacturer segment.
• AdvenaMed (consulting practices): AdvenaMed provides regulatory affairs, quality systems, and clinical strategy consulting for medical device manufacturers — a comparable boutique peer with overlapping 510(k), ISO, and quality system services.

Broad incumbents

• NSF International: NSF provides ISO certification, regulatory consulting, and testing services for medical device, food, and consumer-product companies — a much larger incumbent offering overlapping quality/compliance services to similar customers.
• NAMSA: NAMSA is a global medical-device-focused contract research organization offering regulatory, quality, and testing services — a broader incumbent with overlapping FDA 510(k)/quality system support for medical device clients.
• Parexel International: Parexel is a large global CRO with a regulatory consulting practice serving pharma and medical device companies — much larger scale and broader service portfolio, but directly comparable on regulatory submissions and FDA strategy.

Others

• Covington & Burling (FDA practice): Covington & Burling operates one of the largest FDA regulatory law practices serving pharmaceutical and medical device companies — comparable in serving similar clients with regulatory needs, but as legal counsel rather than a consulting firm.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/mdiConsultants

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

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 mdi Consultants