QES Medical

What QES Medical does

QES Medical LLC is a privately held consulting firm founded in 2009 by Oscar Garcia and headquartered in the Greater Boston Area, providing quality, regulatory, and software development consulting services to the medical device and pharmaceutical industries. The firm helps clients achieve and maintain QMS certification, navigate regulatory clearance, and prepare for QMS audits, with stated experience serving both large companies and startups.

The service portfolio is organized around five core areas: QMS Development and Support (ISO 13485, FDA QSR 21 CFR part 820, 21 CFR part 210/211, 21 CFR part 4); Design Control Support (ISO 13485:2016, 21 CFR 820 Sec. 820.30, IEC 62304, IEC 62366-1); Risk Management and Risk Management File development (ISO 14971:2019); QMS Audits and Audit Readiness Planning; and Training Services across QMS, Risk Management, and Design Control. Adjacent offerings include cleanroom environmental monitoring, combination product compliance, medical device software life cycle processes, supplier control management, and electronic QMS platform implementation referencing 21 CFR part 11. The firm also supports EU MDR compliance and CE marking strategy for European market entry.

QES Medical operates as a professional services business on a project basis or through short/long-term quality team contracts, with no publicly disclosed pricing and engagement initiated via a free 30-minute introductory consultation booked through a website calendar. The firm reports 1-10 employees, is founder-owned and bootstrapped with no external institutional investment, and reaches clients through a content-driven marketing approach including an active blog, LinkedIn and Facebook presence, and a downloadable Audit Readiness Checklist lead magnet. The company is actively hiring and operating as of late 2024, including a posting for a QA Consultant with EU MDR expertise.

Name

QES Medical

Legal name

QES Medical LLC

Website

https://qesmedical.com

Company type

Private

Founded year

2009

Operating status

Operating

Headcount range

11–50 employees

Short description

QES Medical LLC is a Greater Boston-based consulting firm providing quality, regulatory, and software development services to medical device and pharmaceutical companies, helping clients achieve QMS certification, comply with FDA and EU MDR requirements, and prepare for QMS audits.

Ownership category

akta.pro rank

Product category

Medical Device Regulatory Consulting

NAICS

Other Scientific and Technical Consulting Services (541690), Management Consulting Services (54161), Custom Computer Programming Services (541511)

SIC

Services-Management Consulting Services (8742), Services-Computer Programming, Data Processing, Etc. (7370), Services-Health Services (8000)

akta.pro primary industry

Quality Management Systems (QMS) & GxP Documentation (HLAGAKAD)

akta.pro secondary industries

Clinical Quality Assurance (GCP QA, TMF/QMS oversight) (HLAGAKAI), Quality Engineering & Test Automation (QE/QA) (BPAEAFAJ)

Keywords

• Medical device consulting
• Regulatory compliance services
• Quality management systems
• Risk management consulting
• FDA regulatory consulting

Headquarters

HQ city

Salem

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

Revenue model

1. Consulting Services: Revenue generated through consulting engagements offered on a project basis or through short/long-term quality team contracts. Services include QMS development and support, design control, risk management, QMS audits, and training. Contact for pricing model with no publicly disclosed rates.

Pricing tiers

Go-to-market motion1 record

Distribution channels2 records

Marketing channels5 records

Core offering

QES Medical LLC provides quality, regulatory, and software development consulting services to medical device and pharmaceutical companies. Core offerings include Quality Management System (QMS) development and support, design control documentation support, risk management process and file development, audit readiness planning, and structured training in QMS, risk management, and design control. Engagements are delivered on a project basis or through short/long-term quality team contracts.

Product overview

QES Medical LLC is a consulting firm (not a software product company) that offers a portfolio of quality, regulatory, and software development consulting services to the medical device and pharmaceutical industries. The core service offerings include QMS Development and Support, Design Control Support, Risk Management, QMS Audits/Audit Readiness Planning, and Training Services. These are delivered through project-based engagements or short/long-term quality team contracts. The company also offers General Support Services covering cleanroom services, combination product compliance, supplier control management, and electronic QMS platform implementation. Consultation services are available through Free Introductory Consultations (30 min) and General Consultations (1 hour), with specific training programs for QMS, Risk Management, and Design Control.

Differentiator

Problem solved

Functional benefit

Products and services

• Quality Management Systems (QMS) Development and Support Consulting services to develop and maintain Quality Management Systems in accordance with ISO 13485, FDA QSR 21 CFR part 820, 21 CFR part 210/211, and 21 CFR part 4 standards. Delivered on a project basis or via short/long-term quality team contracts to medical device and pharmaceutical companies.
• Design Control Support Support for planning, developing, and maintaining design control documentation for design and development activities in accordance with ISO 13485:2016, FDA 21CFR820 Sec. 820.30, IEC 62304 (Medical Device Software Compliance), and IEC 62366-1 (Usability Engineering). Delivered on a project basis or via short/long-term quality team contracts.
• Risk Management Process and Risk Management File Development or upgrade of risk management processes and product risk management files in accordance with ISO 14971:2019. Delivered on a project basis or via short/long-term quality team contracts to medical device companies.
• QMS Audits and Audit Readiness Planning Preparation of teams to successfully host QMS audits, including a 2-hour Audit Readiness Planning session booked through the company website. Effective techniques are taught to ensure company readiness for upcoming audits.
• Training Services Training sessions covering Design Control, Risk Management, and entire Quality Management Systems for companies or individuals implementing, upgrading, or understanding these processes.
• General Support Services Additional consulting services including cleanroom services (microbial air and surface environmental monitoring), QMS audits and remediation, combination product compliance per 21 CFR part 4 and 21 CFR part 210/211, medical device software life cycle processes, supplier control management, and electronic QMS platform implementation per 21 CFR part 11.
• Free Introductory Consultation 30-minute introductory consultation at no cost to discuss client needs and explore potential quality and regulatory consulting solutions.
• General Consultation 1-hour general consultation service to discuss client needs and explore quality and regulatory solutions; pricing not publicly disclosed.
• Quality Management Systems Training 2-hour overview training session on the elements of a Quality Management System for medical device and pharmaceutical professionals.
• Risk Management Training 2-hour overview training session on the elements of a Risk Management Program aligned with ISO 14971:2019 for medical device professionals.
• Design Control Process Training 2-hour overview training session on the elements of the Design Control Process aligned with ISO 13485:2016 and FDA 21CFR820 Sec. 820.30.

Segments2 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Scale indicators1 record

Recent moves5 records

Expansion highlights6 records

Direct peers

• NAMSA: NAMSA is a global medical device-focused CRO and regulatory/quality consulting firm offering QMS, biological safety, and clinical trial services to med-device manufacturers, directly overlapping with QES Medical's QMS, design control, and risk management offerings.
• Regulatory Compliance Associates (RCA): RCA is a medical device and pharmaceutical regulatory/quality consulting firm delivering QMS development, remediation, and audit support, making it a close direct competitor in the same niche QES Medical targets.
• Veranex: Veranex is an integrated medical device services firm spanning regulatory, quality, clinical, and engineering consulting, directly comparable to QES Medical's QMS and design control support work for med-tech companies.

Emerging players

• Greenlight Guru: Greenlight Guru provides purpose-built eQMS and design control software for medical device companies, competing for the same QMS budget QES Medical serves via consulting.
• Qualio: Qualio offers a cloud eQMS platform purpose-built for life sciences companies, increasingly competing with consulting firms like QES Medical on QMS implementation and documentation work.
• Rimsys: Rimsys delivers regulatory information management software specifically for medical device companies, addressing EU MDR and global registration workflows that overlap with QES Medical's regulatory consulting scope.

Broad incumbents

• MasterControl: MasterControl is a long-standing QMS/eQMS vendor for life sciences with broad capabilities, competing for QMS implementation and audit-readiness spend that QES Medical also targets.
• BSI Group: BSI is a global standards, certification, and regulatory body for ISO 13485 and CE marking, operating as both a competing consultant and certifying body against which QES Medical positions its audit readiness and EU MDR services.
• TÜV SÜD: TÜV SÜD is a major global notified body for medical devices under EU MDR and a broad testing/certification provider, competing for regulatory and audit-related engagements alongside QES Medical.
• NSF International: NSF provides regulatory consulting, training, and certification services across medical devices and pharma, serving as a larger, broader incumbent competing with QES Medical for QMS, audit readiness, and training engagements.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat3 records

Key risks6 records

Key highlights6 records

Customer concentration

• Facebookfacebook.com/QES-Medical-LLC-100064624573966
• LinkedInlinkedin.com/company/qes-medical-llc

Compliance10 records

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 QES Medical