Oriel STAT A MATRIX
Oriel STAT A MATRIX (operating as ELIQUENT Life Sciences) is a regulatory and quality compliance consulting and training firm founded in 1968, serving medical device, IVD, pharmaceutical, and life sciences manufacturers with consulting, auditing, and training across FDA, EU MDR/IVDR, ISO 13485, and emerging standards.
- Company typePrivate
- Founded1968
- HeadquartersUnion, United States
- Headcount101–250
- GTM typeB2B
- OfferingServices
What Oriel STAT A MATRIX does
Oriel STAT A MATRIX, operating since 2021 under the parent brand ELIQUENT Life Sciences (legal entity ELIQUENT Life Sciences, Inc., Delaware), is a regulatory and quality compliance consulting and training firm founded in 1968. It serves medical device, in vitro diagnostic (IVD), pharmaceutical, and broader life sciences manufacturers, along with selected government and infrastructure clients (e.g., Thai Government, Panama Canal Authority, Brazilian Nuclear Power Industry). The company operates through five practice areas — Medical Device RA/QA Consulting, QMS Compliance, Pharmaceutical RA/QA, Performance Excellence/Lean Six Sigma, and Connected Medical Devices/SaMD/IoMT — covering FDA 510(k)/PMA/QMSR, EU MDR (2017/745), EU IVDR (2017/746), ISO 13485, ISO 14971, ISO 27001, MDSAP, ISO/IEC 42001 (AI governance), and IEC 62304 software validation.
The underlying technology base is a domain-specialized regulatory expertise platform rather than a software product: a catalog of 30+ training courses, eLearning courseware, white papers, case studies, and microlearning videos, combined with a senior bench of RA/QA subject matter experts and Lean Six Sigma Black Belts delivered via "Rent an Expert" staff augmentation. Distribution is direct, sales-led (phone 1.800.472.6477 in the US and +353 21 212 8530 in the EU), with public instructor-led classes, virtual instructor-led sessions, DaySmart one-day classes ($995/person), private team training (5+ participants, multi-year contracts possible), and longer-cycle consulting and auditing engagements.
Revenue mechanics blend transactional training (one-time/perpetual license per seat), recurring private team training, and professional-services consulting/auditing/staff augmentation fees. Headcount is 101–250, with offices in Washington, DC (HQ), Union, NJ, and Cork, Ireland (European regional HQ). Cumulative scale signals include 130,000+ auditors trained since 1990 and 1,500+ organizations certified to ISO 9000/AS9100/ISO 13485/ISO/TS 16949/ISO 14000; revenue, funding, and ownership details beyond the ELIQUENT parent are not publicly disclosed.
Oriel STAT A MATRIX firmographics
Firmographics- Name
- Oriel STAT A MATRIX
- Legal name
- ELIQUENT Life Sciences, Inc.
- Website
- https://orielstat.com
- Company type
- Private
- Founded year
- 1968
- Operating status
- Operating
- Headcount range
- 101–250 employees
- Short description
- Oriel STAT A MATRIX (operating as ELIQUENT Life Sciences) is a regulatory and quality compliance consulting and training firm founded in 1968, serving medical device, IVD, pharmaceutical, and life sciences manufacturers with consulting, auditing, and training across FDA, EU MDR/IVDR, ISO 13485, and emerging standards.
- Ownership category
- akta.pro rank
Oriel STAT A MATRIX industry classification
Industry- Product category
- Regulatory Affairs Consulting
- NAICS
- Other Scientific and Technical Consulting Services (54169), Other Scientific and Technical Consulting Services (541690), Professional, Scientific, and Technical Services (541)
- SIC
- Services-Commercial Physical & Biological Research (8731)
- akta.pro primary industry
- Instrumentation, Controls & Automation Engineering Consulting (BPAHAIAM)
- akta.pro secondary industry
- Clinical Quality Assurance (GCP QA, TMF/QMS oversight) (HLAGAKAI)
Keywords
Where Oriel STAT A MATRIX is headquartered
LocationHeadquarters
- HQ city
- Union
- HQ country
- United States
- HQ region
- North America
Offices3 records
Markets served
Oriel STAT A MATRIX business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Marketing or Sales, Technology or R&D, Others
Revenue model
- Training Courses: Public training courses delivered virtually or in-person, including ISO 13485 Lead Auditor, EU MDR Auditor, MDSAP Internal Auditor, and specialized medical device training. Pricing ranges from $995 to $3,295 per course.
- Private Team Training: Customizable, cost-effective training delivered at client facilities or virtually for teams of 5+ participants.
- Consulting Services: RA/QA consulting engagements for regulatory strategy, FDA submissions, EU MDR/IVDR compliance, software validation, and QMS implementation.
- Auditing Services: Internal audits, mock audits, preassessment audits, remote/virtual audits for ISO, FDA, MDSAP, EU MDR, and EU IVDR compliance.
- Staff Augmentation / Rent an Expert: Flexible deployment of experienced RA/QA experts and Lean Six Sigma Black Belts to supplement client organizations.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| One time/ perpetual license | Pay-as-you-go | FDA 21 CFR Part 11 Training - SkillsLab |
| One time/ perpetual license | Pay-as-you-go | Medical Device Supplier Quality Management Training - SkillsLab |
| One time/ perpetual license | Pay-as-you-go | DaySmart Training Classes |
| Other | Pay-as-you-go | Group Discount Program |
| Other | Multi-year contract | Private Team Training |
Go-to-market motion2 records
Distribution channels6 records
Marketing channels8 records
Oriel STAT A MATRIX product offering
Product offeringCore offering
Oriel STAT A MATRIX provides regulatory affairs (RA) and quality assurance (QA) consulting, auditing, and training services for the medical device and pharmaceutical industries. The company helps manufacturers achieve compliance with FDA, EU MDR/IVDR, ISO 13485, MDSAP, QMSR, and related international standards through consulting engagements, instructor-led and self-paced training courses, and staff augmentation programs. Core offerings are organized around five practice areas: Medical Device RA/QA, QMS Compliance, Pharmaceutical RA/QA, Performance Excellence/Lean Six Sigma, and Connected Medical Devices/SaMD/IoMT consulting.
Product overview
Oriel STAT A MATRIX (now operating under ELIQUENT Life Sciences) is a services-based company offering regulatory consulting, auditing, and training for the medical device and pharmaceutical industries. Founded in 1968, the company provides a comprehensive portfolio of professional services organized around five core practice areas: Medical Device RA/QA Consulting (covering EU MDR, FDA submissions, ISO 14971 risk management, and software validation), QMS Compliance Services (including ISO 13485 certification and FDA QMSR implementation), Pharmaceutical RA/QA, Performance Excellence/Lean Six Sigma, and Connected Medical Devices/SaMD/IoMT consulting. The training division offers public instructor-led courses, virtual instructor-led classes, eLearning courseware, private team training, and compact DaySmart sessions. The company operates on a services model with no software products; all offerings are consulting engagements, staff augmentation programs (Rent an Expert), and educational training delivery.
Differentiator
Problem solved
Functional benefit
Products and services
- Medical Device RA/QA Consulting Services Core consulting practice offering regulatory and quality assurance expertise for medical device manufacturers, covering EU MDR (2017/745), FDA submissions (510(k), PMA, IDE, Q-Submission, EUA), ISO 14971 risk management, EU CE Mark certification, EU IVDR compliance, FDA 483 mitigation, software validation, and clinical evaluation reports.
- Quality Management System (QMS) Compliance Services Consulting and auditing services for QMS compliance including ISO 13485 certification consulting, FDA 21 CFR 820/QMSR implementation, MDSAP internal audits, ISO 9001/27001 compliance, FDA 21 CFR Part 11, CAPA and Root Cause Analysis, supplier audits, remote/virtual audits, and management system documentation.
- Pharmaceutical RA/QA Services Regulatory and quality assurance consulting for pharmaceutical companies covering compliance with FDA 21 CFR Parts 210/211, process validation, GMP requirements, and pharmaceutical regulatory submissions.
- Performance Excellence / Lean Six Sigma Consulting Performance improvement consulting combining Lean Six Sigma methodology with Life Sciences regulatory compliance expertise for medical device and pharmaceutical manufacturers seeking enhanced compliance and operational efficiency.
- Connected Medical Devices / SaMD / IoMT Consulting Full life cycle regulatory support for digital medical technology including Software as a Medical Device (SaMD), Internet of Medical Things (IoMT), and connected medical device manufacturers, covering FDA SaMD classification, IEC 62304 compliance, and cybersecurity risk management.
- Staff Augmentation & Rent an Expert Flexible staffing solutions providing Lean Six Sigma Black Belts and FDA regulatory experts to supplement client organizations for specific projects, transitions, or periods of project overload.
- Public Training Courses Instructor-led and virtual training sessions covering medical device RA/QA topics including ISO 13485 Lead Auditor, EU MDR Auditor, MDSAP Internal Auditor, EU IVDR Implementation, and ISO 14971 Risk Management, with CEU credits.
- eLearning - Medical Device RA/QA Courseware Online self-paced learning modules for medical device regulatory and quality assurance professionals, enabling flexible training access for individuals and organizations.
- Private Team Training Customizable in-person or virtual training delivered at client facilities or dedicated sessions for organizational teams of 5 or more participants.
- DaySmart Training Classes
Quantifiable outcome
- 130,000+ auditors trained since 1990
- +3 more outcomes
Companies that use Oriel STAT A MATRIX
Customer profileNamed customers3 records
Segments5 records
Ideal customer profiles3 records
Oriel STAT A MATRIX technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature5 records
Oriel STAT A MATRIX partnerships and signals
Strategic signalPartnerships
Three partnerships are on record, tiered notable.
- Thai GovernmentnotablePartnership with Thai Government to promote economic growth using ISO 9000 standards. Case study documented success in helping government entities implement quality management systems.
- Panama Canal AuthoritynotableISO 9001 implementation partnership resulting in increased profitability and progress for Panama Canal operations. Documented as a case study success story.
- Brazilian Nuclear Power IndustrynotableCapacity building project for Brazilian nuclear power industry through quality management system training and consulting services.
Scale indicators6 records
Recent moves6 records
Expansion highlights6 records
Oriel STAT A MATRIX competitors and assessment
Company assessmentEmerging players
- MEDIcept: Medical device and combination product regulatory, quality, and clinical consulting firm. A more focused/niche peer overlapping with Oriel in FDA submission and QMS compliance services.
Broad incumbents
- Underwriters Laboratories (UL): Global safety science company with a medical device regulatory and quality services practice, including ISO 13485 training and consulting—overlapping with Oriel's QMS and regulatory training portfolio.
- TÜV Rheinland: Global testing, inspection, and certification company with a medical device services portfolio covering ISO 13485 certification, MDSAP, and EU MDR/IVDR support—directly overlapping with Oriel's audit and training services.
- Intertek: Larger global TIC (testing, inspection, certification) and advisory firm serving medical device and pharmaceutical clients. Overlaps with Oriel in regulatory consulting, QMS audits, and training services.
- NSF International: Global public health and safety organization offering medical device QMS consulting, training, and ISO 13485 certification services. Comparable to Oriel in life sciences regulatory advisory and training.
- TÜV SÜD: Global testing, inspection, certification, and training provider with a significant medical device regulatory services portfolio. Competes with Oriel across ISO 13485, MDSAP, EU MDR/IVDR training and consulting engagements.
- BSI Group: Global standards body and certification/consulting provider with deep ISO 13485 and MDR expertise. Overlaps with Oriel in medical device training, certification consulting, and notified-body-adjacent advisory work at much larger scale.
Direct peers
- NAMSA: Medical device-focused CRO and regulatory consulting organization offering regulatory strategy, QMS, testing, and clinical services. Directly comparable to Oriel in medtech RA/QA consulting and staff augmentation.
- RQM+: Medical device regulatory and quality consulting firm offering RA/QA, design, clinical, and post-market services to medtech and IVD manufacturers—directly comparable to Oriel's core RA/QA consulting practice.
- CSSi LifeSciences: Specialized life sciences regulatory, quality, and clinical consulting firm serving medtech and pharma. Competes with Oriel in FDA submission support, EU MDR consulting, and QMS implementation.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks6 records
Key highlights7 records
Customer concentration
Oriel STAT A MATRIX social profiles
Digital presenceOriel STAT A MATRIX financial estimates
Financial estimateRevenue estimate
Valuation estimate
Oriel STAT A MATRIX leadership team
Management profileNumber of profiles
Profiles3 records
Oriel STAT A MATRIX funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Oriel STAT A MATRIX M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Oriel STAT A MATRIX
What does Oriel STAT A MATRIX do?
Oriel STAT A MATRIX provides regulatory affairs (RA) and quality assurance (QA) consulting, auditing, and training services for the medical device and pharmaceutical industries. The company helps manufacturers achieve compliance with FDA, EU MDR/IVDR, ISO 13485, MDSAP, QMSR, and related international standards through consulting engagements, instructor-led and self-paced training courses, and staff augmentation programs. Core offerings are organized around five practice areas: Medical Device RA/QA, QMS Compliance, Pharmaceutical RA/QA, Performance Excellence/Lean Six Sigma, and Connected Medical Devices/SaMD/IoMT consulting.
Is Oriel STAT A MATRIX a public or private company?
Oriel STAT A MATRIX is a private company. It is classified as corporate owned and is currently operating.
When was Oriel STAT A MATRIX founded?
Oriel STAT A MATRIX was founded in 1968. It employs 101 to 250 people.
Where is Oriel STAT A MATRIX based?
Oriel STAT A MATRIX is headquartered in Union, United States, in the North America region.
How does Oriel STAT A MATRIX make money?
Five revenue lines are on record. Training Courses are the primary driver. The others are private Team Training, consulting Services, auditing Services and staff Augmentation / Rent an Expert.
Who are Oriel STAT A MATRIX's main competitors?
MEDIcept is listed as an emerging player. Broad incumbents are Underwriters Laboratories (UL), TÜV Rheinland, Intertek, NSF International, TÜV SÜD and BSI Group. Direct peers are NAMSA, RQM+ and CSSi LifeSciences.
Does Oriel STAT A MATRIX have an API?
No public API is recorded for Oriel STAT A MATRIX.
What industry is Oriel STAT A MATRIX in?
Oriel STAT A MATRIX's product category is Regulatory Affairs Consulting. Its primary akta.pro industry code is BPAHAIAM, Instrumentation, Controls & Automation Engineering Consulting, with a secondary code of HLAGAKAI, Clinical Quality Assurance (GCP QA, TMF/QMS oversight). Its NAICS code is 54169 and its SIC code is 8731.