ProMedoss

What ProMedoss does

ProMedoss, Inc. is a privately held, founder-led regulatory and clinical consulting firm headquartered in Charlotte, North Carolina, serving medical device companies from early-stage startups through enterprise manufacturers. The firm is led by Founder and Managing Director Shoshana Friedman (RAC, FRAPS; recipient of the 2005 Richard E. Greco Award from RAPS; 30+ years of regulatory affairs experience) and Managing Director Bosmat Friedman (MSc in Regulatory Affairs, Northeastern University; consultant since 2007), supported by a total headcount of 1-10 employees.

The firm's service portfolio spans four integrated pillars: Regulatory Services (FDA 510(k), PMA, IDE, and pre-sub strategy and submissions; EU MDR and Canadian market entry), Clinical Trial Services (project management, site monitoring, EDC, data management, and statistical analysis from feasibility through pivotal studies), QMS Compliance + Support (ISO 13485, QSR, and CAN/CSA ISO 13485 establishment, internal audits, mock FDA/NB audits, gap analysis, and FDA inspection representation), and Due Diligence Services for investors and acquirers. These are supplemented by US Designated Agent representation for foreign manufacturers, PRRC services for EU MDR compliance, and tailor-made on-site training. The underlying technology is human domain expertise applied via professional services engagements; there are no proprietary software platforms, APIs, AI/ML systems, or patented assets.

The business operates on a quote-based, project-by-project professional services model with no publicly disclosed pricing. Go-to-market is direct enterprise/field sales, driven by the founders' personal credibility, FDA relationships, and client referrals, with marketing conducted through the firm's website and LinkedIn presence. The client base documented in public testimonials spans seven named medical device organizations (Aqua Medical, EndoGI Medical, Virility Medical, Hospitech Respiration, ARK Surgical, Greiner Bio-One North America, Nostromo Energy) with several relationships lasting 5-6+ years. The firm is bootstrapped with no institutional funding, no parent company, and no recorded M&A or partnership activity.

Name

ProMedoss

Legal name

ProMedoss, Inc

Website

https://promedoss.com

Company type

Private

Operating status

Operating

Headcount range

1–10 employees

Short description

ProMedoss is a founder-led medical device regulatory and clinical consulting firm based in Charlotte, NC, serving startups through enterprise manufacturers with FDA submissions, EU MDR compliance, clinical trial management, and QMS services across US, European, and Canadian markets.

Ownership category

akta.pro rank

Product category

Medical Device Regulatory Consulting

NAICS

Management Consulting Services (54161), Research and Development in the Physical, Engineering, and Life Sciences (54171)

SIC

Services-Management Consulting Services (8742), Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Clinical Operations & Monitoring FSP (CRA/CTM/Start-up) (HLAGAOAA)

Keywords

• Medical device regulatory consulting
• Clinical trial management
• Quality management systems
• FDA submission services
• Regulatory affairs consulting

Headquarters

HQ city

Charlotte

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, Technology or R&D, Infrastructure

Revenue model

1. Regulatory Consulting Services: Professional consulting services for medical device regulatory affairs including strategy development, submissions to regulatory agencies (510(k), PMA, IDE, pre-sub), and regulatory compliance throughout the product lifecycle.
2. Clinical Trial Services: Comprehensive clinical trial management services including project management, site monitoring, data management, and regulatory document preparation for feasibility through pivotal studies.
3. QMS Compliance and Support: Quality Management System establishment, internal audits, mock regulatory audits, gap analysis, and FDA inspection representation services.
4. Due Diligence Services: In-depth audit and analysis of market and regulatory environment for investors, acquirers, or firms evaluating medical device companies and novel technologies.
5. Training Services: Tailor-made on-site training in Quality Assurance, regulatory matters, and clinical matters. Also includes PRRC (Person Responsible for Regulatory Compliance) services for EU MDR compliance.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels5 records

Core offering

ProMedoss is a professional consulting firm that helps medical device startups and entrepreneurs bring devices to market through regulatory affairs, clinical trial management, and Quality Management System (QMS) compliance services. Its offerings span FDA regulatory submissions (510(k), PMA, IDE, pre-sub packages), full-scope clinical trial management from feasibility to pivotal studies, ISO 13485/QSR QMS establishment and audits, regulatory due diligence for investors, US Designated Agent representation for foreign companies, and tailored on-site training.

Product overview

ProMedoss is a consulting firm that provides a unified portfolio of regulatory, quality, and clinical services for medical device startups and entrepreneurs. The core offering consists of four integrated service pillars: Regulatory Services (covering FDA strategy and submissions), Due Diligences (market and regulatory assessment), QMS Compliance + Support (ISO 13485/QSR compliance), and Clinical Trial Services (feasibility through pivotal studies). These are supplemented by Additional Services including US Agent representation, PRRC services for European MDR, and customized training programs. Together, these services guide clients from concept through market entry in a streamlined, cost-effective manner.

Differentiator

Problem solved

Functional benefit

Quantifiable outcome

• Secured three 510(k)s in record time for Aqua Medical
• +3 more outcomes

Named customers7 records

Segments3 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

Scale indicators3 records

Recent moves4 records

Expansion highlights4 records

Direct peers

• Maetrics: Maetrics is a life sciences regulatory and quality compliance consultancy providing GxP, ISO 13485, and FDA submission support. It competes with ProMedoss for medical device clients needing QMS and regulatory affairs services.
• NAMSA: NAMSA is a medical device-focused CRO and consulting firm offering regulatory, quality, and clinical services to medical device manufacturers. Like ProMedoss, it supports FDA submissions and QMS compliance, but at significantly greater scale.
• MCRA (Musculoskeletal Clinical Regulatory Advisers): MCRA provides regulatory, clinical, and quality consulting specifically for medical device companies, including reimbursement and healthcare economics. It is a direct competitor in the medical device regulatory consulting space where ProMedoss operates.
• RCRI (Regulatory & Clinical Research Institute): RCRI is a medical device-focused consulting firm offering regulatory affairs, clinical trial management, and quality system services. It mirrors ProMedoss's boutique service model targeting medical device startups and manufacturers.
• BioExcel Consulting: BioExcel is a boutique regulatory affairs and quality compliance consultancy serving medical device and pharmaceutical companies. It competes directly with ProMedoss for FDA submission and QMS engagements from startups and mid-market manufacturers.

Broad incumbents

• Parexel International: Parexel is a major global CRO with regulatory consulting and clinical trial services. While primarily pharma-focused, it competes with ProMedoss for larger medical device sponsors needing integrated regulatory and clinical capabilities.
• IQVIA: IQVIA is a global CRO and life sciences services giant offering regulatory, clinical, and quality consulting. It overlaps with ProMedoss's clinical trial and regulatory services at the enterprise end of the medical device market.
• Charles River Laboratories: Charles River Laboratories is a broad life sciences CRO offering preclinical, clinical, and regulatory services. It overlaps with ProMedoss in regulatory and clinical support, especially for larger medical device and combination product clients.

Others

• Hogan Lovells (Medtech Regulatory Practice): Hogan Lovells is a global law firm with a leading medical device regulatory practice offering FDA strategy, submissions, and EU MDR support. It competes with ProMedoss for high-stakes regulatory strategy engagements, though delivered through legal counsel rather than consulting.

Emerging players

• Greenlight Guru: Greenlight Guru provides QMS software purpose-built for medical device companies, addressing the same ISO 13485/QSR compliance pain points ProMedoss serves via consulting. It represents a technology-enabled emerging alternative in ProMedoss's core QMS market.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• Facebookfacebook.com/promedoss
• LinkedInlinkedin.com/company/promedoss

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 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 ProMedoss