CMD MedTech

What CMD MedTech does

CMD MedTech is a Columbus, Ohio-based, woman-owned small business operating as a boutique medical device consulting firm. Founded in 2016 by CEO Melissa Masters and CTO Chad Gibson, with Felicia Hobson as COO and Managing Partner, the firm provides specialized consulting services across the FDA-regulated medical device development lifecycle. Its primary customer base consists of medical device startups needing regulatory pathway guidance and quality system establishment, alongside established manufacturers seeking specialized regulatory, quality, systems engineering, cybersecurity, and usability engineering support. The senior team averages 20–35+ years of medical device industry experience and has collectively contributed to developing hundreds of devices spanning surgical robots, body-worn sensors, and diagnostic equipment, with dozens of direct FDA interactions over the past five years.

The firm's offering is organized around four pillars: medical device engineering, regulatory affairs, quality systems, and project and program management, supported by dedicated IVD/LDT and cybersecurity practices. Beyond pure consulting, CMD MedTech markets Astro, a proprietary 21 CFR Part 11-compliant electronic document management and electronic signature system distributed on a subscription basis to small and medium medical device manufacturers. The firm also publishes proprietary methodologies, including a "right-sized" quality system framework tailored to device classification and risk profile, and a model-based systems engineering reference architecture for medical devices. CEO Melissa Masters co-authored the foundational AAMI TIR57 technical information report on medical device security, providing differentiated thought leadership in a domain where formal FDA cybersecurity guidance arrived later.

Revenue is generated primarily through time-and-materials and fixed-price consulting engagements, supplemented by subscription fees from the Astro platform. Pricing is fully quote-based with no published rate cards, and engagements are customized to device classification, scope, and regulatory pathway. Distribution is direct-only, with no resellers or channel partners; sales are handled internally by a business development manager and senior technical leadership via consultative, relationship-driven outreach. Marketing is concentrated on thought leadership content (technical blog, white papers, conference presentations) optimized for SEO around regulatory keywords, supplemented by active memberships in RAPS, Ohio Life Sciences, INCOSE, and HBA. All operations are conducted from a single Columbus, Ohio headquarters with services delivered to clients nationwide in the United States.

Name

CMD MedTech

Legal name

CMD MedTech LLC

Website

https://cmdmedtech.com

Company type

Private

Founded year

2016

Operating status

Operating

Headcount range

11–50 employees

Short description

CMD MedTech is a Columbus, Ohio-based, woman-owned medical device consulting firm providing FDA regulatory strategy, quality system development, systems engineering, cybersecurity, and usability services to medical device startups and established manufacturers across the United States.

Ownership category

akta.pro rank

Product category

Medical Device Regulatory Consulting

NAICS

Scientific Research and Development Services (5417), Research and Development in the Physical, Engineering, and Life Sciences (54171)

SIC

Services-Health Services (8000)

akta.pro primary industry

Clinical Trial Informatics (EDC/CTMS/eCOA/eTMF) (HLAGAJAM)

Keywords

• Medical device consulting
• FDA regulatory services
• Quality system development
• Medical device engineering
• Medical device cybersecurity

Headquarters

HQ city

Columbus

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Consulting and Professional Services: CMD MedTech generates revenue primarily through billable consulting and professional service engagements. Services include regulatory strategy, quality system development, systems engineering, software development, cybersecurity, usability engineering, and project management. Engagements are structured as time-and-materials or fixed-price contracts, with both models tailored to client scope and requirements. Pricing is quote-based and customized per engagement.
2. Astro Electronic Document Management Platform: The company offers its proprietary Astro 21 CFR Part 11-compliant electronic document control system as a product offering, likely on a subscription or license basis, to medical device companies seeking compliant electronic records management. This represents a software product revenue stream alongside the services business.

Pricing tiers

Go-to-market motion2 records

Distribution channels2 records

Marketing channels5 records

Core offering

CMD MedTech is a woman-owned medical device consulting firm that provides FDA regulatory consulting, quality system development, systems engineering, software development, cybersecurity, and usability engineering services to medical device companies ranging from startups to established manufacturers. The firm guides medical device development from concept through market launch with hands-on project management and direct FDA engagement, and also sells Astro, a proprietary 21 CFR Part 11-compliant electronic document control system, as a standalone software product.

Product overview

CMD MedTech is a woman-owned medical device consulting firm offering a portfolio of specialized services rather than a unified software product. Their core offerings span medical device engineering, regulatory affairs (FDA and international), quality systems, and project management consulting. The company offers Astro, their proprietary 21 CFR Part 11-compliant electronic document control system, as their primary named product for electronic records and signatures. Supporting service lines include IVD regulatory consulting, PMCF services, IEC 60601-1 compliance, usability/human factors engineering, cybersecurity, and software development under IEC 62304. The portfolio is structured around end-to-end medical device development guidance from concept through market launch and post-market surveillance.

Differentiator

Problem solved

Functional benefit

Products and services

• Astro Electronic Document Control System A proprietary 21 CFR Part 11-compliant electronic document management and electronic signature system designed for small- to medium-sized medical device companies. Provides compliant electronic records management with validation documentation to support internal compliance with FDA electronic record requirements. Sold on a monthly subscription basis.
• Medical Device Engineering Services Systems engineering and technical leadership covering safety risk management, cybersecurity, compliance programs (IEC 60601-1, IEC 62304, IEC 62366-1), requirements development, verification, validation, and human factors for medical device and combination product development.
• Medical Device Regulatory Services Regulatory consulting including 510(k), PMA, De Novo, 513(g) submissions, Q-submissions, eSTAR, regulatory strategies, remediation, technical file construction, IEC 60601-1 compliance, post-market clinical follow-up, and EU MDR/IVDR compliance.
• Medical Device Quality Services Quality system development and management compliant with 21 CFR 820, ISO 13485, document control, audit support, and quality system training for medical device manufacturers.
• Project & Program Management Services Medical device project management including schedule, budget, program risk management, earned value tracking, KPI development, and due diligence assessments.
• In Vitro Diagnostics (IVD) Regulatory Services IVD regulatory consulting for FDA diagnostic test approval, quality management for laboratory tests, and CDx commercialization support.
• Laboratory Developed Tests (LDT) Services FDA LDT regulation guidance including quality management system development, implementation support, medical device reporting, and test documentation validation.

Quantifiable outcome

• Fixing a problem during requirements phase costs approximately $1,000 vs. $100,000 during testing vs. millions post-launch

Segments4 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Five partnerships are on record, tiered minor.

• Priority DesignsminorStrategic or Co-development PartnerPriority Designs is a specialized design and human factors firm that CMD MedTech partners with for extensive expertise in designing and conducting summative evaluations and early formative evaluations for medical device usability engineering. The partnership allows CMD MedTech to offer comprehensive human factors services by leveraging Priority Designs' specialized capabilities for complex multi-site studies.
• Ohio Life SciencesminorOthersCMD MedTech is a proud member of Ohio Life Sciences, a regional industry association serving the life sciences and medical technology community in Ohio. Membership provides networking, advocacy, and visibility within the regional medical device ecosystem.
• RAPS (Regulatory Affairs Professionals Society)minorOthersCMD MedTech is a proud member of RAPS, the leading global organization for regulatory affairs professionals in healthcare products. Several team members hold RAPS Regulatory Affairs Certifications (RAC), and membership supports professional development and industry credibility.
• INCOSE (International Council on Systems Engineering)minorOthersCMD MedTech is a proud member of INCOSE, the International Council on Systems Engineering. Membership demonstrates commitment to systems engineering best practices and provides access to industry standards and professional networks.
• HBA (Healthcare Businesswomen's Association)minorOthersCMD MedTech is a proud member of the Healthcare Businesswomen's Association, aligning with its woman-owned small business identity and commitment to empowering female engineers, inventors, and entrepreneurs in the healthcare and medical device industry.

Scale indicators4 records

Recent moves5 records

Expansion highlights5 records

Direct peers

• Greenlight Guru: Greenlight Guru provides a quality management system platform purpose-built for medical device companies, paired with regulatory and quality consulting services. It directly competes with CMD MedTech on both the consulting engagement model and the Astro EDMS-style product offering.
• RQM+: RQM+ is a medical device regulatory and quality consulting firm offering services across FDA submissions, quality systems, and clinical regulatory affairs. It competes head-to-head with CMD MedTech for the same medical device startup and established manufacturer client base.
• NAMSA: NAMSA is a global medical device-focused CRO offering regulatory, quality, clinical, and testing services. It is the largest scaled competitor in the same medical device consulting category as CMD MedTech, particularly relevant for clients needing lab testing and clinical evidence alongside regulatory work.
• Kymanox: Kymanox is a medical device and combination product consulting firm offering regulatory, quality, engineering, and compliance services. It is a direct peer to CMD MedTech for medical device startups and established manufacturers, with comparable service breadth and engagement model.
• MedAcuity: MedAcuity is a medical device software engineering consultancy specializing in IEC 62304, cybersecurity, and regulated software development. It directly overlaps with CMD MedTech's software development, cybersecurity, and systems engineering service lines for the same medical device client base.
• Proxima Clinical Research: Proxima Clinical Research is a medical device-focused CRO providing regulatory, clinical trial management, and quality services. It competes with CMD MedTech on the regulatory and quality consulting side for medical device manufacturers pursuing FDA pathways.

Broad incumbents

• MasterControl: MasterControl is an established eDMS/QMS platform serving medical device, pharmaceutical, and broader life sciences manufacturers. Its quality and document management software suite directly competes with CMD MedTech's Astro product, and its professional services arm competes for the same consulting engagements.
• Veeva Systems: Veeva provides life sciences regulatory, quality, and clinical software platforms (including Vault QualityDocs and Vault eDMS). It competes with the Astro EDMS offering and serves many of the same large medical device manufacturers CMD MedTech targets.
• IQVIA: IQVIA is a global life sciences services and technology provider spanning clinical, regulatory, and technology offerings. While much larger and broader than CMD MedTech, it competes for medical device regulatory consulting engagements and its technology platforms compete with Astro.
• Battelle: Battelle is a large applied science and technology organization that performs medical device R&D, regulatory, and systems engineering work. It serves many of the same medical device manufacturers and federal health agencies as CMD MedTech but at much greater scale.

Market position

Strengths2 records

Weaknesses5 records

Competitive moat3 records

Key risks6 records

Key highlights7 records

Customer concentration

Compliance5 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles14 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 CMD MedTech