leanRAQA

What leanRAQA does

leanRAQA is a U.S.-based regulatory affairs and quality assurance consulting firm specializing in medical devices and biotechnology, founded in 2011 by Michelle Lott and organized as leanRAQA LLC in Washington State. The firm operates with a team of approximately ten and has cumulatively supported the market entry of more than 200 medical devices across its history. Core services span regulatory strategy, regulatory submissions (510(k), de novo, PMA, pre-submissions), quality systems and compliance consulting, audit management and FDA inspection support, due diligence, EU MDR/IVDR compliance, fractional quality assurance leadership, and delegated technical support covering risk, usability, engineering, and testing protocols.

The firm's customer base is concentrated in medical device startups and small-to-mid-sized manufacturers, with a secondary use case serving investors and strategic acquirers conducting regulatory due diligence on medtech targets. leanRAQA monetizes exclusively through professional services billed on an engagement-specific, quote-based pricing model; no public pricing exists. Distribution is primarily direct, supported by an extensive owned-media content engine — a blog, YouTube channel, SoundCloud podcast (RAQA Today), free downloadable assessment guides, and fee-based online courses hosted on Kajabi — plus referrals and speaking engagements at institutions such as Johns Hopkins and Galway Medical Institute. The firm has no proprietary software platform; its defensibility rests on founder credibility (FDA advisory committee service), specialized regulatory expertise, and accumulated content assets. leanRAQA is privately held, founder-owned, and has no external institutional investment or acquisitions on record.

Name

leanRAQA

Legal name

leanRAQA LLC

Website

https://leanraqa.com

Company type

Private

Founded year

2011

Operating status

Operating

Headcount range

1–10 employees

Short description

leanRAQA is a U.S. regulatory affairs and quality assurance consulting firm that helps medical device startups and SMBs navigate FDA submissions, build quality management systems, manage audits, and achieve EU MDR compliance, led by founder Michelle Lott.

Ownership category

akta.pro rank

Product category

Medical Device Regulatory Consulting

NAICS

Management Consulting Services (54161), Other Management Consulting Services (541618), Other Scientific and Technical Consulting Services (54169)

SIC

Services-Management Consulting Services (8742)

akta.pro primary industry

Pharmacovigilance Quality & Compliance (PV audits, QPPV support, PSMF) (HLAGAKAH)

akta.pro secondary industries

Audit, Inspection & Quality Compliance (Internal Auditing, CAPA) (EDABAKAN), Quality Assurance (QA), Coaching & Performance Management (EDABACAF)

Keywords

• Regulatory affairs consulting
• Quality assurance services
• Medical device compliance
• FDA submissions support
• EU MDR compliance

Headquarters

HQ city

West Pima County

HQ country

United States

HQ region

North America

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Regulatory Affairs & Quality Assurance Consulting: leanRAQA generates revenue through professional consulting services for medical device companies, encompassing regulatory strategy, regulatory submissions, quality systems compliance, audit management, due diligence, and technical support. Fees are quote-based and engagement-specific, with no public pricing listed.

Go-to-market motion1 record

Distribution channels3 records

Marketing channels7 records

Core offering

leanRAQA is a regulatory affairs and quality assurance consulting firm that helps medical device companies navigate FDA and EU MDR regulatory pathways, develop and maintain quality management systems, prepare and submit 510(k), de novo, PMA, and pre-submission filings, manage audits and FDA inspections, and conduct regulatory due diligence. The firm supplements its consulting practice with paid online courses (covering CAPA, Management Review, and QMSR) delivered through a Kajabi learning platform and a library of free guides and thought-leadership content.

Product overview

leanRAQA is a regulatory affairs and quality assurance consulting firm specializing in medical devices. The company offers a comprehensive suite of consulting services including Regulatory Strategy, Regulatory Submissions (510(k) and pre-submissions), Quality Systems and Compliance, Audit Management, Due Diligence, Technical Support, EU MDR Services, and Fractional Quality Assurance. The firm also provides free educational resources including the Regulatory Pathways Assessment Guide and Market Assessment Guide, as well as fee-based online courses through its Kajabi-hosted learning platform covering topics like CAPA, Management Review, and QMSR. leanRAQA operates as a services firm rather than a software product company.

Differentiator

Problem solved

Functional benefit

Products and services

• Regulatory Strategy Services Consulting engagement that defines the most direct regulatory path to achieve a medical device project's objectives, maximizing compliance, expediting commercialization, and saving time and money for medical device companies.
• Regulatory Submissions Services Preparation and submission of regulatory applications for medical devices, including 510(k) submissions and pre-submissions, with thorough examination for completeness and accuracy and clear demonstration of safety, efficacy, and regulatory compliance.
• Quality Systems and Compliance Services Quality management system consulting scaled to a medical device company's size, activity, and requirements, focused on product safety outcomes and rapid crisis response, aligned with QMSR, ISO 13485, and EU MDR.
• Audit Management Services End-to-end audit support for medical device companies, including pre-audit preparation, conducting internal and supplier audits, and managing FDA inspections to help clients achieve a clean bill of health rather than a 483 or warning letter.
• Due Diligence Services Product pathway assessment and extensive documentation review to mitigate regulatory liabilities and risks, helping medical device investors and acquirers avoid costly remediation in target deals.
• Technical Support Services Delegated technical support covering risk, usability, engineering, testing, reporting, and other medical device compliance protocols, allowing clients to focus on market activities.
• EU MDR Services European Union Medical Device Regulation compliance consulting to help medical device manufacturers navigate MDR requirements and obtain market entry in Europe.
• Fractional Quality Assurance Services Part-time or fractional quality assurance leadership for medical device companies that need senior QA oversight without a full-time hire.
• leanRAQA Online Courses Self-paced online courses including Back to Basics: CAPA, Management Review, and Understanding and Implementing QMSR, hosted on a Kajabi platform (lean-team.mykajabi.com), available for individual purchase by regulatory and quality professionals.

Quantifiable outcome

• 200+ medical devices brought to market
• +1 more outcomes

Named customers13 records

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

Three partnerships are on record, tiered minor.

• WuXi AppTecminorOthersWuXi AppTec experts Sandi Schaible and Mike McGrew contributed insights to a leanRAQA podcast episode on biocompatibility testing and fraudulent data, providing testing lab perspective on ASCA accreditation, lab selection criteria, and FDA data integrity expectations.
• Arazy Group ConsultantsminorGTM or Marketing PartnerleanRAQA founder Michelle Lott was invited to participate in Arazy Group's Regulatory Rockstar Movement, a thought leadership initiative that features interviews and content from regulatory affairs experts. This placement expands leanRAQA's visibility within the regulatory professional community.
• Fernda Nusbaum (TTi)minorStrategic or Co-development PartnerFernda Nusbaum from TTi co-presented with Michelle Lott from leanRAQA on a market pathway webinar covering regulatory, reimbursement, and commercialization alignment for MedTech companies.

Scale indicators1 record

Recent moves6 records

Expansion highlights3 records

Direct peers

• MCRA (Musculoskeletal Clinical Regulatory Advisers): MCRA is a medical device regulatory and clinical consulting firm supporting FDA submissions, quality systems, and reimbursement. It competes head-to-head with leanRAQA in 510(k)/de novo/PMA strategy and QMS support for medtech clients.
• Proxima Clinical Research: Proxima is a medical device-focused CRO offering regulatory affairs, clinical research, and quality services. It is a closely comparable boutique peer serving early-stage medtech companies.
• Biologics Consulting Group: Biologics Consulting Group is an FDA regulatory and product development consultancy covering medical devices, biologics, and drugs. It is a direct peer for medical device RA/QA strategy work.
• RCRI: RCRI provides regulatory, clinical, and quality consulting specifically for medical device and diagnostics companies. It overlaps directly with leanRAQA's startup-to-commercialization service portfolio.
• NAMSA: NAMSA is the largest medical device-focused contract research organization, offering regulatory affairs, quality systems, and clinical services to medtech manufacturers. It is the most direct competitor to leanRAQA's full-lifecycle RA/QA offering, though at much greater scale.
• Greenleaf Health: Greenleaf Health is an FDA regulatory consulting firm advising medical product companies on strategy, submissions, and policy. It is a comparable boutique peer with deep FDA relationships, similar in positioning to leanRAQA.
• Regulatory Compliance Associates (RCA): RCA provides quality, regulatory, and compliance consulting for life sciences, with a strong medical device practice. It directly competes in QMS, audit, and submission support.

Broad incumbents

• TÜV SÜD: TÜV SÜD is a global notified body and testing organization offering EU MDR conformity assessment, ISO 13485 certification, and medical device regulatory services. It competes with leanRAQA on the EU MDR side at much broader scale.
• Underwriters Laboratories (UL): UL provides regulatory compliance, testing, and certification services for medical devices, including standards-based assessments. It is a broader incumbent overlapping with leanRAQA's audit and compliance offerings.
• BSI Group: BSI is a major notified body issuing CE marks under EU MDR/IVDR and providing ISO 13485 certification. It is an established incumbent in the same regulatory compliance category as leanRAQA.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat3 records

Key risks6 records

Key highlights6 records

Customer concentration

• YouTubeyoutube.com/c/leanRAQA/videos?sub_confirmation=1
• Xx.com/LeanRAQA
• Facebookfacebook.com/leanraqasystems
• LinkedInlinkedin.com/company/lean-raqa-systems

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 leanRAQA