What MedReg Consulting does

MedReg Consulting, LLC is a Boulder, Colorado-based regulatory and clinical affairs consultancy focused on medical devices. The firm advises medical product companies on FDA submissions, CE Mark, EU MDR/IVDR compliance, ISO 13485 quality systems, IEC 62304 medical device software, risk management, and clinical evaluation reports. Its principal consultant, Elizabeth Malo, brings 20+ years of experience and a track record of 200+ device registrations, and the firm extends its clinical research delivery through a partnership with Medicore International. The service is delivered as quote-based professional consulting rather than a packaged product or platform.

The firm serves two principal client segments: small and midsize medical device companies that lack in-house regulatory depth, and well-established international medical product companies executing multi-jurisdictional market entry. Coverage explicitly spans the United States, Japan and broader Asia Pacific, Canada, the EU, and Latin America, with service offerings adapted to the regulatory regime of each jurisdiction. Advisory work has been extended into emerging categories such as AI-enabled medical devices and Software as a Medical Device (SaMD), reflecting demand for regulatory guidance as new device types reach market.

The operating model is a small, principal-led practice with the firm listed at 1-10 employees. Revenue is generated through project-based engagements priced by quote, with regulatory submissions and clinical evaluation reports as the core deliverables. There is no indication of outside funding, investor involvement, or recurring SaaS-style revenue. The business is therefore best characterized as a boutique consulting firm whose value is concentrated in the expertise and reputation of its founder rather than in scalable technology infrastructure.

Name

MedReg Consulting

Legal name

MedReg Consulting, LLC

Website

https://medicalregulatory.com

Company type

Private

Operating status

Operating

Headcount range

1–10 employees

Short description

MedReg Consulting is a Boulder, Colorado-based regulatory affairs consultancy that helps medical device companies with FDA, CE Mark, EU MDR/IVDR, ISO 13485, and IEC 62304 submissions, serving SMEs and international device firms across the US, Asia Pacific, EU, Canada, and Latin America.

Ownership category

akta.pro rank

Headquarters

HQ city

Boulder

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, Others

Revenue model

1. Regulatory Affairs Consulting Services: Professional consulting services for regulatory strategy, submissions, and compliance for medical devices. Services include due diligence research, product development pipeline support, market landscape assessment, target market planning, product classification, design requirements, applicable standards, risk management, verification and validation testing, protocol design and testing, data review and reporting, Unique Device Identification, MDR & IVDR remediation, and CLIA Lab compliance support.
2. Clinical/Medical Affairs Services: Clinical strategy and study execution services including clinical study planning, protocol design, IRB/EC approvals, study monitoring, medical monitoring, data review and analysis, clinical study reports, literature reviews, clinical evaluation reports (CER), medical writing, and publications support.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels1 record

Core offering

MedReg Consulting, LLC is a regulatory and clinical affairs consulting firm that maps and implements regulatory and clinical strategy for medical device development, design changes, and continued compliance. Services span FDA submissions, CE Mark technical files, MDR/IVDR compliance, ISO 13485, global device registrations, and clinical study execution, delivered through principal consultant Elizabeth Malo in partnership with Medicore International.

Product overview

MedReg Consulting, LLC is a regulatory affairs consulting firm that provides regulatory and clinical strategy services for medical device development, design changes, and continued compliance. The company operates as a services-based consultancy rather than a software product platform. Its core offerings include Regulatory Affairs Consulting (strategic planning, due diligence, FDA submissions, CE Mark technical files, global registrations, ISO 13485 compliance, MDR/IVDR compliance) and Clinical/Medical Affairs Services (clinical study planning, protocol design, study execution, medical writing). The services encompass specialized areas such as Medical Device Software & AI, In vitro Diagnostics (IVDs), Combination Products, and Laboratory Developed Tests with CLIA Lab support. The firm partners with Medicore International, Inc. for clinical expertise to deliver comprehensive regulatory and clinical solutions to small to medium-sized enterprises and established international medical products companies.

Differentiator

Problem solved

Functional benefit

Products and services

• Regulatory Affairs Consulting End-to-end regulatory affairs support covering strategy, due diligence, design controls, and continued compliance activities for medical device development, design changes, and ongoing regulatory maintenance, delivered to small and mid-sized medical device manufacturers and established international medical products companies.
• Clinical/Medical Affairs Services Clinical and medical affairs consulting including clinical strategy, study design, protocol development, study monitoring, study report writing, and medical writing for medical device companies pursuing regulatory approvals.
• FDA Submissions Preparation Preparation and execution of U.S. FDA regulatory submissions for medical devices, including 510(k), PMA, IDE, and other premarket and post-market submission types.
• CE Mark Technical Files Compilation and management of CE Mark technical files and design dossiers for EU market entry of medical devices.
• MDR and IVDR Compliance Services Advisory and implementation services for EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) compliance, including technical documentation and clinical evidence strategy.
• Global Medical Device Registration Services Global device registration support across multiple jurisdictions beyond the U.S. and EU, leveraging experience with public health authorities worldwide to file and maintain device market authorizations.
• Quality System Regulation / ISO 13485 Compliance Services Implementation and maintenance support for ISO 13485 quality management systems and U.S. Quality System Regulation (QSR) compliance for medical device manufacturers.
• Medical Device Software and AI Services Specialized regulatory support for medical device software and AI-enabled devices, including IEC 62304 lifecycle processes and related FDA and EU expectations.
• In Vitro Diagnostics Services Regulatory affairs consulting specific to in vitro diagnostics (IVDs), including IVDR compliance, technical documentation, and clinical evidence requirements.
• Combination Products Services Regulatory strategy and submission support for combination products (drug-device, biologic-device combinations), addressing cross-jurisdictional regulatory expectations.
• Laboratory Developed Tests / CLIA Lab Services Regulatory and quality consulting for Laboratory Developed Tests (LDTs) and CLIA-certified laboratories, including compliance with CLIA requirements and LDT regulatory frameworks.

Named customers2 records

Segments1 record

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.

• Medicore International, Inc.coreStrategic or Co-development PartnerMedReg partners with clinical experts at Medicore International, Inc. to plan, implement, and effectively meet clinical activity requirements. This partnership provides clients with reliable safety data through streamlined business activities. Working with Medicore International, MedReg ensures clinical strategies meet regulatory requirements and manages all aspects of clinical validation including clinical study planning, protocol design, IRB/EC approvals, study monitoring, data review and analysis, and clinical evaluation reports.

Scale indicators2 records

Recent moves4 records

Expansion highlights4 records

Direct peers

• Freyr Solutions: Regulatory affairs and compliance services firm with strong medical device and IVD coverage across global markets. Competes directly for FDA, EU MDR/IVDR, and global registration work.
• Makro Technologies: Regulatory affairs consulting firm focused on medical devices, IVDs, and combination products with FDA, EU, and global registration expertise. Closely comparable niche positioning.
• NAMSA: Medical device-focused CRO and regulatory consulting organization providing regulatory strategy, clinical trial support, and testing services. Comparable client base (medical device manufacturers) and end-to-end regulatory/clinical service model.
• RQM+: Specialized medical device regulatory and quality consulting firm offering FDA submissions, CE Mark, ISO 13485, and global registrations. Highly comparable service mix to MedReg, typically at larger scale.
• Biologics Consulting Group: Regulatory consulting firm spanning drugs, biologics, and medical devices. Overlaps directly with MedReg on FDA submissions and combination product strategy, though broader in modality.
• Eurofins Medical Device Consulting: Medical device testing, certification, and regulatory consulting arm of Eurofins. Comparable regulatory submission, CE Mark, and global market access services at significantly larger scale.

Broad incumbents

• Medpace: Mid-sized global CRO with regulatory affairs capabilities for medical device and biopharma sponsors. Provides regulatory submissions as part of larger clinical development programs.
• IQVIA: Global CRO and life sciences services firm with a substantial regulatory affairs practice. Comparable regulatory strategy work but bundled into a much broader clinical, data, and commercial portfolio.

Emerging players

• PharmaLex: Regulatory and pharmacovigilance consulting firm with growing medical device capabilities. Comparable regulatory consulting model, though anchored more heavily in pharma.
• Greenlight Guru: Quality management and regulatory workflow software purpose-built for medical device companies. Represents a substitution and tooling threat to traditional regulatory consulting, especially for ISO 13485/QMS work.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks5 records

Key highlights6 records

Customer concentration

• Facebookfacebook.com/MedReg-Consulting-LLC-100072113059272
• LinkedInlinkedin.com/company/medreg-consulting-llc

Compliance5 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 MedReg Consulting