What Rallis-Daw Consulting does

Rallis-Daw Consulting LLC is a woman-owned medical device consulting firm headquartered in San Clemente, California, founded in 2021 by Stephanie Rallis-Daw, who serves as President & CEO. The firm provides quality management system (QMS/eQMS) implementation and management, regulatory affairs support, technical writing, clinical services, audit execution, and project management to medical device manufacturers and MedTech startups navigating FDA QMSR (21 CFR Part 820) transitions, EU MDR compliance, ISO 13485:2016, MDSAP, and AS 9100D requirements. Consultants average over 20 years of industry experience, and the CEO concurrently works as a lead auditor and technical documentation reviewer for a Notified Body, providing direct visibility into current regulatory expectations across therapeutic areas including ophthalmic, radiology, cardiology, gastroenterology/urology, orthopedic, neurology, dental, and Software as a Medical Device (SaMD).

The firm operates two trademarked branded offerings: Ablest-eQMS, an electronic QMS delivered as a pay-as-you-go monthly subscription on the Cognidox platform spanning document control, training management, design control, audit management, CAPA, nonconformance reporting, risk management, supplier management, and regulatory submission management; and Napkin-to-Market, a structured program guiding medical device innovators from concept through regulatory approval, clinical evaluation, market entry, and post-market surveillance by coordinating contract manufacturers, testing laboratories, and clinical research organizations. A broader portfolio of project-based professional services covering quality, regulatory, clinical, technical, and mentoring engagements supplements these productized offerings.

Revenue is generated through two streams: customized professional services engagements (quote-based, not publicly priced) and Ablest-eQMS subscriptions. The go-to-market motion is sales-led and event-driven: the firm co-founded the invite-only MedTech South OC Network in early 2025 alongside C6 Systems to generate lead flow in the Southern California MedTech ecosystem, supplemented by content marketing through the 'Tales from the Audit Crypt' blog and YouTube channel, and supported by reciprocal alliances with QMS software vendors (Cognidox, Qualio, Greenlight Guru, Grand Avenue Software, Dot Compliance), clinical and test providers (Evnia, PRN Medical Solutions, WESTPAK), and product development partners (MedTechWare, Tight Line Solutions). Lifetime operating metrics of 750+ clients acquired, 30+ products brought to market, and 10+ audits completed anchor the firm's track record.

Name

Rallis-Daw Consulting

Legal name

Rallis-Daw Consulting LLC

Website

https://rallis-dawconsulting.com

Company type

Private

Founded year

2021

Operating status

Operating

Headcount range

11–50 employees

Short description

Rallis-Daw Consulting LLC is a woman-owned medical device consulting firm serving manufacturers and MedTech startups with quality management system implementation, regulatory affairs support, and end-to-end product development services via its Ablest-eQMS and Napkin-to-Market programs.

Ownership category

akta.pro rank

Product category

Medical Device 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

EHS Management Systems & ISO Consulting (ISO 14001/45001) (BPAHAJAF)

akta.pro secondary industry

Medical Affairs, Scientific Communications & HEOR FSP (HLAGAOAG)

Keywords

• Medical device consulting
• Quality management systems
• Regulatory compliance services
• EQMS implementation
• Medical device compliance

Headquarters

HQ city

San Clemente

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Professional Consulting Services: Consulting engagements providing quality management system implementation and management, CAPAs, training, audit execution, regulatory strategies, submissions, remediation, compliance, technical writing, validation, statistical analyses, clinical services, and project management. Services are tailored to client needs.
2. Ablest-eQMS Subscription: Monthly subscription-based eQMS service where clients pay as they go for quality management system development, implementation, and maintenance. Clients can add or remove elements and support services as needed. The QMS remains owned by the client after development.

Pricing tiers

Go-to-market motion2 records

Distribution channels2 records

Marketing channels7 records

Core offering

Rallis-Daw Consulting provides professional consulting services to medical device companies, covering quality management system (QMS/eQMS) implementation, regulatory affairs, clinical services, technical writing, validation, auditing, and project management. The firm also offers Ablest-eQMS, a monthly subscription electronic quality management system powered by Cognidox, and the Napkin-to-Market program that guides innovators through the full medical device product development lifecycle from concept to post-market surveillance.

Product overview

Rallis-Daw Consulting is a woman-owned medical device consulting firm offering a portfolio of consulting services and technology-enabled solutions. The core offerings include Ablest-eQMS (an eQMS platform powered by Cognidox) and Napkin-to-Market (a product development program), complemented by Quality Services, Regulatory Affairs, Technical Services, Clinical Services, Project Management, and Mentoring. The company specializes in supporting medical device companies through full quality management system implementation, gap analyses and remediation, technical writing, regulatory submissions, program management, organizational training, and women empowerment initiatives.

Differentiator

Problem solved

Functional benefit

Brands

• Ablest-eQMS: A comprehensive electronic Quality Management System (eQMS) powered by Cognidox, offering QMS development, implementation, and maintenance services including document control, training management, audit management, CAPA, risk management, and regulatory submission support.
• Napkin-to-Market

Products and services

• Ablest-eQMS A comprehensive electronic Quality Management System (eQMS) offering QMS creation, document and record control, training management, design control, audit management, CAPA, nonconformance reports, risk management, supplier management, regulatory submission management, and equipment management. Delivered as a monthly subscription service for medical device companies.
• Napkin-to-Market Program A comprehensive program that guides medical device innovators through the entire product development lifecycle, from ideation through regulatory submissions, market entry, and post-market surveillance. Includes dedicated project management, access to contract manufacturers, testing laboratories, clinical research organizations, and regulatory guidance.
• Quality Services QMS/eQMS implementation and management, CAPAs, training, and audit execution across MDSAP, EU MDR, ISO 13485:2016, QMSR, sterilization, AS 9100D, and ISO/IEC 17025 standards for medical device and life sciences clients.
• Regulatory Affairs Services Regulatory strategy, submissions, remediation, compliance support, EU MDR and QMSR (FDA 21 CFR Part 820) transitions, and pre-due diligence review services for medical device manufacturers.
• Technical Services Technical writing, validation, verification and qualification plans, statistical analyses, and test laboratory sourcing for medical device companies.
• Clinical Services Site qualification, site monitoring, study audits, and TMF/eTMF preparation and maintenance for medical device clinical programs.
• Project Management Services Project planning, plan execution, and resource allocation and management for medical device product development and quality initiatives.
• Mentoring Professional mentoring services for industry professionals in the medical device and life sciences sector.

Quantifiable outcome

• 30+ products brought to market
• +2 more outcomes

Segments3 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration1 record

Feature2 records

Partnerships

Eight partnerships are on record, tiered core and minor.

• C6 SystemscoreStrategic or Co-development Partner · 1 January 2025C6 Systems is co-founding the MedTech South Orange County Network along with Stephanie Rallis-Daw and Jack Hamilton. Stan Schroeder is President and Jack Hamilton is CEO of C6 Systems.
• EvniacoreStrategic or Co-development PartnerEvnia enables manufacturers developing medical and in-vitro diagnostics devices worldwide to remain in compliance with clinical, IVD, and technical documentation requirements. They announced a new strategic partnership with Rallis-Daw Consulting LLC.
• CognidoxcoreTechnology or IntegrationCognidox provides document and data management solutions for research, development, and technology-focused businesses. Their platform powers the Ablest-eQMS offering, providing the technical infrastructure for the eQMS solution.
• QualiominorGTM or Marketing PartnerCloud-based quality management software provider for life sciences. Rallis-Daw Consulting was featured as a top medical device consultant on Qualio's platform.
• MedTechWareminorStrategic or Co-development PartnerProduct development partner specializing in embedded systems, electronics, firmware, Software as a Medical Device (SaMD), and connected cloud and mobile platforms.
• PRN Medical SolutionsminorStrategic or Co-development PartnerDelivers comprehensive Human Factors and Usability Engineering services including testing labs, participant recruitment, market research, and SW Quality & Design Assurance support.
• Tight Line SolutionsminorStrategic or Co-development PartnerPartners with product development teams to solve execution challenges and build capability for confident performance.
• WESTPAK, Inc.minorImplementation/ SI/ Consulting PartnerThird-party independent test laboratory specializing in product and package testing, ISTA Certified Laboratories.

Scale indicators5 records

Recent moves5 records

Expansion highlights6 records

Direct peers

• Kapstone Medical: Medical device consulting firm covering regulatory strategy, clinical, quality systems, and product development. Comparable in services offered and in serving early- to mid-stage medical device companies.
• RQM+: Medical device regulatory and quality consulting provider with a focus on FDA, EU MDR, and ISO 13485. Competes head-on with Rallis-Daw in the same niche, with a similar productized-services go-to-market.
• MEDIcept: Medical device and IVD consulting practice with regulatory affairs, clinical, and quality systems offerings. Closely matches Rallis-Daw's blend of consulting and clinical services for medtech clients.
• BioTeknica: Medical device quality and regulatory consulting firm supporting QMS, CAPA, audit, and remediation work. Closely overlaps with Rallis-Daw's quality and regulatory services portfolio and medical device customer base.
• The FDA Group: Specialized medical device and pharmaceutical consulting firm offering quality, regulatory, and compliance services to life sciences companies. Directly comparable to Rallis-Daw in target customer, service mix, and boutique scale.

Emerging players

• Qualio: Cloud eQMS for life sciences companies and the publisher of the 'Top Medical Device Consultants' lists that recognized Rallis-Daw. An ecosystem partner but also a competitor for bundled software-plus-services deals.
• Greenlight Guru: Cloud-based eQMS platform purpose-built for medical device companies, with an adjacent consulting and implementation partner network. Competes with the Ablest-eQMS offering and is listed as one of Rallis-Daw's technology partners.
• Dot Compliance: Compliance management software provider for life sciences, with an implementation and consulting partner channel. Competes for QMS implementation budgets and is a Rallis-Daw technology partner.

Broad incumbents

• NSF: Global testing, inspection, certification, and consulting organization with a medical device and health sciences division. Competes in the same regulatory and QMS consulting space but at much larger scale and broader scope.
• TÜV SÜD: Global certification and testing body with medical device regulatory and quality services, including ISO 13485 certification and EU MDR support. A Notified Body competitor with overlapping services and broader geographic reach.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• YouTubeyoutube.com/@talesfromtheauditcrypt
• LinkedInlinkedin.com/company/rallis-daw-consulting-llc
• Instagraminstagram.com/rallisdawconsulting

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 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 Rallis-Daw Consulting