MAE Group

What MAE Group does

MAE Group is a privately held, founder-led professional services firm headquartered in Manchester, New Hampshire that provides commercialization consulting to medical device and in vitro diagnostic device companies. The firm operates across five core service lines — Regulatory Affairs, Artificial Intelligence and Machine Learning, Quality System Management, Design and Development Engineering, and Project Management — packaged into three client-segmented tiers (Early Stage, Small & Medium Enterprise, Blue Chip). The customer base consists of medical device manufacturers and IVD developers, with documented engagements including EU CE Mark submissions (Neopenda NeoGuard for neonatal vital signs monitoring in Kenya), FDA recall management (1,557-unit knee brace recall terminated within 3 months), ISO 13485 quality system remediation, and IVD regulatory strategy.

The company generates revenue through project-based and retainer consulting engagements, with pricing delivered via quote rather than published rate cards. Its go-to-market relies on consultative B2B engagement, industry summit participation (Marcus Evans Medical Device Summit), thought-leadership content, and educational events (MedTech Start-up to Market). In 2016, MAE Group extended into Europe through MAE Consulting Group (Europe) Ltd in Manchester, UK to access UK/EU clients seeking US market entry support.

Alongside consulting, MAE Group has run an internal product program since 2019 — Project Hope — developing a thermobrachytherapy (TBT) oncology device that combines hyperthermia with brachytherapy for glioblastoma treatment. The technology, transferred from Thomas Jefferson University researcher Paul Stauffer, is at NIH Phase I STTR feasibility stage (grant R41CA239815, awarded 2021) with Phase II funding and a GoFundMe campaign underway. MAE Group is a wholly owned subsidiary of MAE Enterprises, a holding company, and has not disclosed external institutional investment.

Name

MAE Group

Legal name

MAE Group

Website

https://maegroups.com

Company type

Private

Founded year

2013

Operating status

Operating

Headcount range

1–10 employees

Short description

MAE Group is a Manchester, NH-based consulting firm providing regulatory affairs, quality systems, AI/ML integration, design engineering, and project management services to medical device and IVD companies, while internally developing a thermobrachytherapy oncology device.

Ownership category

akta.pro rank

Product category

Medical Device Regulatory & Commercialization Consulting

NAICS

Management Consulting Services (54161), Other Scientific and Technical Consulting Services (541690)

SIC

Services-Management Consulting Services (8742)

akta.pro primary industry

Healthcare IT & Health Informatics Staffing (BPACADAK)

akta.pro secondary industries

Digital & AI-Enabled Diagnostics (algorithmic interpretation, decision support tied to assays) (HLAAALAO), EHR Implementation, Optimization, Training & Managed Services (HLACAAAL)

Keywords

• Medical device consulting
• Regulatory affairs services
• Quality systems management
• Medical device commercialization
• AI/ML medical devices

Headquarters

HQ city

Manchester

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Consulting Services Revenue: MAE Group generates revenue through providing professional consulting services including regulatory affairs, quality systems management, design engineering, AI/ML integration, and project management. Services are likely structured as project-based engagements or retainer arrangements with healthcare companies seeking to commercialize medical devices and IVDs in target markets.

Go-to-market motion1 record

Distribution channels3 records

Marketing channels5 records

Core offering

MAE Group provides consulting services for medical device and in-vitro diagnostic device commercialization, spanning Regulatory Affairs, AI/ML integration, Quality System Management, Design and Development Engineering, and Project Management. The firm also internally develops Project Hope, a thermobrachytherapy (TBT) oncology device platform for glioblastoma treatment, supported by an NIH Phase I STTR grant.

Product overview

MAE Group is a business solution provider offering a comprehensive suite of services for medical device and in vitro diagnostic device commercialization. Their core service portfolio includes Regulatory Affairs Services, Artificial Intelligence and Machine Learning Services, Quality System Management, Design and Development Engineering, and Project Management. These services are structured into solution tiers targeting Early Stage Companies, Small & Medium Enterprises, and Blue Chip manufacturers. Additionally, MAE Group is internally developing Project Hope - a thermobrachytherapy oncology device platform technology for treating glioblastoma. The company serves as a capstone between inventors and investors, bringing medical technologies to global markets.

Differentiator

Problem solved

Functional benefit

Products and services

• Regulatory Affairs Services

Quantifiable outcome

• Achieved EU CE Mark approval for Neopenda's NeoGuard vital signs monitor, enabling market launch in Kenya, Africa.
• +3 more outcomes

Named customers4 records

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability2 records

Feature3 records

Partnerships

Five partnerships are on record, tiered minor and core.

• Manchester Community CollegeminorStrategic or Co-development Partner · 4 December 2024MAE Group partnered with Manchester Community College to host the MedTech Start-up to Market event on December 4, 2024, designed to assist MedTech startups in navigating the commercialization process.
• Marcus Evans GroupminorGTM or Marketing Partner · 7 December 2021MAE Group participated in the Marcus Evans Medical Device Summit, one of the industry's premiere events connecting medtech innovators with service providers. CEO Janet Kwiatkowski and Jay Wigley attended the summit in Orlando, Florida.
• Advanced Sterilization Technology Inc (AST)minorStrategic or Co-development PartnerAST is a Taiwan-based company specializing in precision manufacturing of fasteners and screws. MAE Group highlights AST as part of their strategic alliances for medical device manufacturing support.
• Paul StauffercoreStrategic or Co-development PartnerPaul Stauffer, retired Professor and Director of Thermal Oncology Physics from Thomas Jefferson University, is a key member of Project Hope's Advisory Team. He pioneered thermobrachytherapy research over 40 years and transferred the technology to MAE Group for commercialization.
• Dr. Wenyin ShicoreStrategic or Co-development PartnerDr. Wenyin Shi, Professor of Radiation Oncology and Neurological Surgery at Thomas Jefferson University, serves on Project Hope's Advisory Team. He received the 2021 Sidney Kimmel Medical College Outstanding Clinician Award and has developed multiple investigator-initiated trials.

Scale indicators3 records

Recent moves7 records

Expansion highlights6 records

Direct peers

• Qserve Group: Qserve is a global consulting firm specializing in regulatory affairs, clinical research, and quality compliance for medical devices and IVDs. Directly comparable offering and customer profile to MAE Group, with deeper European footprint.
• NAMSA: NAMSA is a global medical device-focused CRO offering regulatory, quality, and testing services. Directly comparable to MAE Group's regulatory affairs and quality system consulting for medtech/IVD, though operating at significantly larger scale.
• RCRI (Regulatory & Clinical Research Institute): RCRI provides regulatory affairs, quality systems, and clinical research services exclusively to medical device and IVD manufacturers. Closely comparable niche, target customers, and service portfolio to MAE Group.

Emerging players

• BioTeknica: BioTeknica is a smaller regulatory and quality consulting firm focused on IVD and medical device companies. Comparable boutique, customer-aligned niche peer to MAE Group, particularly on IVD regulatory work.
• Greenlight Guru: Greenlight Guru is a purpose-built QMS and medical device workflow platform. It represents the software/productized alternative to MAE Group's consulting-led quality system support for medtech companies.

Broad incumbents

• MasterControl: MasterControl provides QMS, document management, and compliance software widely used by medical device manufacturers. Comparable in serving the same medtech regulatory/quality buyer as MAE Group, but via a software platform rather than consulting services.
• Eurofins Medical Device Testing: Eurofins provides testing, certification, and regulatory consulting services to the medical device industry globally. Adjacent incumbent with overlapping regulatory/quality capability for medtech and IVD manufacturers.
• TÜV SÜD (Medical & Health Services): TÜV SÜD is a global testing, inspection, and certification firm with a dedicated Medical & Health Services practice. Overlaps with MAE Group's regulatory and quality work, particularly for EU CE Marking, as a broad incumbent.
• Underwriters Laboratories (UL) Solutions: UL Solutions offers safety science, testing, certification, and advisory services across medical device and healthcare. Overlaps with MAE Group's regulatory and quality system remit as a broad incumbent.
• BSI Group (MedTech): BSI is a standards body and notified body offering ISO 13485 certification, CE marking support, and regulatory consulting for medical devices. Overlaps with MAE's CE Mark and ISO 13485 work, but operates as a much larger incumbent.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat3 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/mae-consulting-group-llc
• Xx.com/maeconsult

Revenue estimate

Valuation estimate

Number of profiles

Profiles9 records

Subsidiaries1 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 MAE Group