Name

MD101 Consulting

Legal name

MD101 Consulting

Website

https://md101consulting.com

Company type

Private

Founded year

2013

Operating status

Operating

Headcount range

1–10 employees

Ownership category

akta.pro rank

Headquarters

HQ city

Aubagne

HQ country

France

HQ region

Europe

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. Strategic & Operational Consulting Services: MD101 generates revenue through bespoke consulting engagements serving medical device manufacturers throughout all phases of product development. Services include QARA (Quality Assurance & Regulatory Affairs), Clinical & Reimbursement support, Business & Marketing strategy, and Operational Management. The company also serves as an Operating Partner for healthcare investment funds, providing due diligence and portfolio company support.
2. Professional Training Services: MD101 offers certified training programs (Qualiopi certified) for healthcare professionals on regulatory requirements, cybersecurity, and quality management for medical devices. Training is delivered through both inter-enterprise (public) and intra-enterprise (in-house) formats, covering topics such as FDA regulations, IEC standards, and AI in medical devices.

Go-to-market motion1 record

Distribution channels3 records

Marketing channels4 records

Core offering

MD101 Consulting is a healthtech consulting firm that helps medical device manufacturers, digital health companies, and healthcare investment funds navigate complex regulatory frameworks and access international markets. The firm delivers bespoke services across Quality Assurance & Regulatory Affairs (QARA), Clinical & Reimbursement, Business & Marketing, and Operating Partner engagements, complemented by a Qualiopi-certified training catalog of 58 courses.

Product overview

MD101 Consulting is a healthtech consulting firm offering a unified platform of professional services for medical device companies (DM, DMDIV, digital health) seeking to enter and expand across regulated international markets. The service portfolio comprises four core offerings: QARA (Quality Assurance & Regulatory Affairs), Clinique & Remboursement, Business & Marketing, and Operating Partner services for investment funds. These are delivered through an integrated cross-functional approach covering strategic consulting, product conception, quality assurance, cybersecurity, regulatory affairs, clinical affairs, reimbursement, commercial strategy, and operational management. Additionally, MD101 offers a structured training catalog (Formations Dispositif Médical) with 58 courses certified under Qualiopi, addressing topics including FDA regulations, IEC standards, AI in medical devices, and cybersecurity requirements. The company has served over 1,200 clients ranging from startups to large enterprises since its founding.

Differentiator

Problem solved

Functional benefit

Products and services

• QARA (Quality Assurance & Regulatory Affairs)

Quantifiable outcome

• 1,200+ companies served since founding
• +2 more outcomes

Segments2 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Partnerships

Two partnerships are on record, tiered core.

• The Alliance EMT (Experts MedTech)coreStrategic or Co-development PartnerMD101 is a member of The Alliance EMT (Experts MedTech), an alliance of companies united to support healthcare businesses. This partnership provides access to a broader network of MedTech experts across Europe for collaborative client support.
• The MedTechAlliance (USA)coreStrategic or Co-development PartnerMD101 is a founding member of The MedTechAlliance, a partnership focused on providing trusted support for healthcare companies seeking to enter or expand in the US market. This alliance offers US market expertise and regulatory guidance for European medical device companies.

Scale indicators6 records

Recent moves1 record

Expansion highlights5 records

Broad incumbents

• NSF: Global public health and safety organization providing medical device certification, testing, and consulting services. Broad incumbent with overlapping MedTech regulatory, quality, and training capabilities across multiple jurisdictions.
• TÜV SÜD: Global testing, inspection, and certification organization with significant medical device services including regulatory consulting. Broad incumbent offering overlapping capabilities in MedTech quality, safety, and regulatory compliance.
• IQVIA: Global healthcare and life sciences consulting and data analytics giant. Offers overlapping capabilities in regulatory affairs, market access, and clinical consulting for medical device and pharma clients at scale MD101 cannot match.
• BSI Group: Global certification, testing, and standards body offering medical device regulatory and quality consulting alongside its core certification business. Broader incumbent with overlapping MedTech compliance and regulatory advisory capabilities.

Direct peers

• Qserve Group: Netherlands-based medical device regulatory and quality consulting firm operating across Europe and globally. Directly comparable as a European MedTech consultancy serving similar startups and mid-market device manufacturers navigating CE marking and FDA pathways.
• NAMSA: Global medical device-focused contract research organization offering regulatory, quality, clinical, and testing services to MedTech manufacturers. Directly comparable in scope of regulatory and clinical expertise for medical device clients.
• Alira Health: US-headquartered global medical device and healthcare consulting firm offering regulatory, clinical, and commercial services to medical technology companies. Closely comparable to MD101's integrated MedTech service portfolio and target client base.
• ProPharma Group: Life sciences consulting firm specializing in regulatory compliance, quality assurance, and pharmacovigilance for medical product companies. Comparable boutique specialty consulting model targeting medical device and pharmaceutical manufacturers.

Emerging players

• Greenlight Guru: Medical device quality management system (QMS) software platform. Emerging tech-enabled player addressing regulatory and quality workflows that MD101 currently supports through bespoke consulting engagements.
• Rimsys: Regulatory affairs management software platform for medical device companies. Emerging technology-led alternative to traditional regulatory consulting that could partially substitute MD101's core QARA service offering.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat3 records

Key risks5 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/md101-consulting
• Xx.com/MD101consulting

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

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 MD101 Consulting