Med-device Consulting, Inc.

What Med-device Consulting, Inc. does

Med-device Consulting, Inc. (legal entity MED-DEVICE CONSULTING, Inc.) is a privately-held US regulatory and quality consulting firm founded in 1999 and headquartered in Los Angeles, California (Calabasas). The firm provides specialized advisory services to medical device, cosmetic, personal lubricant, vaginal suppository, and nutraceutical manufacturers seeking US FDA clearance and European market access. Its core service is the preparation and submission of FDA 510(k) premarket notifications, with particular depth in personal lubricants (water-based and silicone-based formulations, flavored options, heated massage lotions, toy cleaners, arousal serums, skincare solutions) and vaginal suppositories. Supporting services include ISO 13485:2016 quality system development, MDSAP, CE marking, biocompatibility and testing support, risk assessment, FDA establishment registration and US Agent services, GMP training, and post-authorization regulatory operations including 483 response, recall management, and remediation planning.

The firm operates a project-based professional services model, billing clients on engagement-by-engagement work for FDA submissions, ISO compliance, risk assessments, and market entry strategy. Pricing is quote-based and not publicly disclosed. GTM is direct and sales-led, leveraging the company website, email outreach, and professional referrals (the latter reinforced by client testimonials such as Cabeca Health Institute recommending lead consultant "Louie"). The firm serves four named segments: medical device companies (primary), personal lubricant manufacturers (primary), women's health product companies, and international companies entering the US market. It describes its team as carrying "over 30 years" of combined regulatory and chemistry experience across US and European frameworks, and claims to have helped "hundreds of small and large firms" navigate regulatory hurdles. Headcount is reported in the 1–10 range with no disclosed revenue, funding, or institutional ownership.

Name

Med-device Consulting, Inc.

Legal name

MED-DEVICE CONSULTING, Inc.

Website

https://m-dci.us

Company type

Private

Founded year

1999

Operating status

Operating

Headcount range

1–10 employees

Short description

Med-device Consulting is a Los Angeles-based regulatory and quality consulting firm founded in 1999 that prepares FDA 510(k) submissions and ISO/CE compliance documentation for medical device, personal lubricant, and vaginal suppository manufacturers.

Ownership category

akta.pro rank

Product category

Medical Device Regulatory Consulting

NAICS

Other Scientific and Technical Consulting Services (54169), Other Management Consulting Services (541618)

SIC

Services-Management Consulting Services (8742)

akta.pro industry

PRIMARYHLAGAOAC

Medical Writing & Clinical Documentation FSP

Healthcare & Life Sciences/Life Science Tools & Services (CRO/CDMO/Lab Services)/Scientific Staffing & Functional Service Providers (FSP)

SECONDARYHLAGALAK

Patient Support Programs & Device/Vaccine Vigilance (PSP/PSUR support)

Healthcare & Life Sciences/Life Science Tools & Services (CRO/CDMO/Lab Services)/Pharmacovigilance & Medical Affairs Services

SECONDARYHLAGALAE

Medical Information Services (MI Contact Centers)

Healthcare & Life Sciences/Life Science Tools & Services (CRO/CDMO/Lab Services)/Pharmacovigilance & Medical Affairs Services

Keywords

• FDA regulatory consulting
• 510(k) submissions
• Medical device compliance
• Quality systems consulting
• Regulatory strategy services

Headquarters

HQ city

Calabasas

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Marketing or Sales

Revenue model

1. Regulatory Consulting Services: Professional consulting services for FDA submissions, ISO compliance, risk assessments, and market strategy for medical devices. Services are provided on a project, temporary, or ongoing basis to assist companies in meeting strategic objectives.

Go-to-market motion2 records

Distribution channels1 record

Marketing channels3 records

Core offering

Med-Device Consulting, Inc. provides regulatory and quality consulting services for medical device manufacturers, with a primary focus on preparing and submitting FDA 510(k) premarket notifications. The firm has particular specialization in personal lubricants and vaginal suppositories and supports clients through regulatory strategy, quality system design, clinical study planning, and labeling/promotion review.

Product overview

Med-Device Consulting is a regulatory consulting firm established in 1999, providing a comprehensive suite of FDA regulatory services primarily focused on 510(k) premarket submissions for personal lubricants, vaginal suppositories, and women's health products. The company offers quality system development and ISO 13485:2016 compliance consulting, risk assessment services, GMP training programs, and market entry strategy support for both US and European markets. The core offering centers on FDA 510(k) submission services augmented by supporting services including regulatory compliance reviews, FDA registration assistance, biocompatibility testing support, and remediation consulting. The portfolio is organized around a single integrated service model where regulatory expertise, quality systems, and compliance support work together to guide clients from initial product analysis through final FDA clearance and ongoing market maintenance.

Differentiator

Problem solved

Functional benefit

Products and services

• FDA 510(k) Submission Services
• Quality System Regulation (QSR) Consulting
• Clinical Study Design for Device Submissions
• Label and Promotion Review

Quantifiable outcome

• Successful FDA 510(k) clearance for clients
• +1 more outcomes

Named customers2 records

Segments4 records

Ideal customer profiles1 record

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature1 record

Partnerships

One partnership is on record.

• CALICMminorOthersCALICM is referenced as a partner on the Med-Device Consulting website under the 'Our Partners' section. The partnership appears to be a collaborative relationship within the medical device consulting and compliance industry.

Scale indicators3 records

Recent moves5 records

Expansion highlights4 records

Broad incumbents

• Parexel International: Large global CRO with regulatory affairs capabilities spanning medical devices and pharma; broader portfolio than Med-Device Consulting but overlapping on FDA submission strategy and lifecycle regulatory support.
• ICON plc: Global CRO providing regulatory, clinical, and quality services across pharma and medical devices. A broad incumbent whose regulatory consulting practice overlaps with Med-Device Consulting's FDA submission focus at much larger scale.
• TÜV SÜD: Global testing, inspection, and certification organization providing ISO 13485, CE marking, MDSAP, and medical device regulatory services. Comparable to Med-Device Consulting on quality systems and international market access, but as a broad incumbent.
• BSI Group: Global standards body and certification provider offering ISO 13485 certification, CE marking, and regulatory advisory for medical devices. Overlaps with Med-Device Consulting on ISO compliance and EU market access, but operates at much larger scale.

Direct peers

• Emergo by UL: Medical device regulatory and quality consulting firm specializing in FDA 510(k) submissions, EU MDR/CE marking, and international market access. Direct peer to Med-Device Consulting on regulatory pathway consulting for device manufacturers.
• NAMSA: Medical device-focused CRO and regulatory consulting organization offering biocompatibility testing, quality systems, and FDA submission support. Comparable service portfolio targeting device manufacturers seeking regulatory clearance.
• BioTeknica: Regulatory and quality compliance consulting firm serving medical device and pharmaceutical companies with FDA submission, CAPA, and remediation services. Direct boutique-style peer in the same regulatory consulting space.
• Regulatory Compliance Associates (RCA): Life sciences regulatory and quality consulting firm providing FDA 510(k), ISO 13485, and remediation support to medical device manufacturers. Comparable service mix and customer profile to Med-Device Consulting.
• MCRA (Medical Device Regulatory, Clinical, Reimbursement & Quality): Specialized medical device consultancy providing regulatory strategy, 510(k)/PMA submissions, clinical and quality services. Closely comparable business model and customer base, serving device manufacturers across multiple specialties.
• RQM+ (formerly R&Q Consulting): Specialist medical device regulatory and quality consulting firm offering 510(k) preparation, ISO 13485, and FDA submission services. Direct competitor to Med-Device Consulting in the same product/customer category, but operating at significantly larger scale.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat3 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/med-device-consulting-inc.

Compliance4 records

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 Med-device Consulting, Inc.