Oriel STAT A MATRIX (Document Control & SOP Training)
Oriel STAT A MATRIX
Oriel STAT A MATRIX offers expert QA/RA consulting, auditing, and training for the life sciences industry. They specialize in medical device compliance, AI governance, and regulatory transitions like QMSR and EU AI Act.
Oriel STAT A MATRIX provides specialized QA/RA consulting, auditing, and training services tailored for the life sciences sector. They assist organizations in meeting complex regulatory requirements, enhancing operational efficiency, and ultimately improving patient outcomes. Their expertise covers critical areas such as EU MDR compliance, ISO 27001 ISMS, software validation, risk management (ISO 14971), and FDA software classification. Oriel STAT A MATRIX is at the forefront of regulatory changes, offering training and guidance on emerging standards like AI Governance for Life Sciences (ISO 42001) and navigating the FDA's QMSR transition to an ISO 13485-based framework. They also provide support for integrating AI into medical devices and understanding the implications of the EU AI Act alongside MDR/IVDR. For those needing rapid upskilling without intensive multi-day courses, their "DaySmart" training classes offer a flexible and cost-effective solution. Whether you are a startup requiring short-term RA/QA expertise or an established company facing project overload, Oriel STAT A MATRIX can provide the necessary support to ensure seamless compliance and market access.
About
**Who they are**
Oriel STAT A MATRIX (Document Control & SOP Training) is a long-standing QA/RA consulting, auditing, and training firm, founded in 1968, specializing in regulatory compliance for the life sciences industry. They are now part of ELIQUENT Life Sciences, offering an expanded suite of services.
**Expertise & scope**
* Expertise in medical device compliance, AI governance, and regulatory transitions such as QMSR and the EU AI Act.
* Services include QA/RA consulting, auditing, and training.
* Focus areas encompass EU MDR (2017/745) Compliance, ISO 27001 ISMS & Cybersecurity, Software Validation and Verification, ISO 14971 Risk Management, EU CE Mark Certification, FDA Software Classification, Lean Six Sigma, and EU MDR Gap Analysis.
* Support for clients in the EU and US markets.
**Reputation / proof points**
* Founded in 1968, making them the oldest quality improvement training and consulting firm in the US.
* Part of ELIQUENT Life Sciences, a group of regulatory consultancies offering a broader array of services and expertise.
* Clients trust them for deep subject matter expertise and proven ability to deliver long-term results.
Oriel STAT A MATRIX (Document Control & SOP Training) is a long-standing QA/RA consulting, auditing, and training firm, founded in 1968, specializing in regulatory compliance for the life sciences industry. They are now part of ELIQUENT Life Sciences, offering an expanded suite of services.
**Expertise & scope**
* Expertise in medical device compliance, AI governance, and regulatory transitions such as QMSR and the EU AI Act.
* Services include QA/RA consulting, auditing, and training.
* Focus areas encompass EU MDR (2017/745) Compliance, ISO 27001 ISMS & Cybersecurity, Software Validation and Verification, ISO 14971 Risk Management, EU CE Mark Certification, FDA Software Classification, Lean Six Sigma, and EU MDR Gap Analysis.
* Support for clients in the EU and US markets.
**Reputation / proof points**
* Founded in 1968, making them the oldest quality improvement training and consulting firm in the US.
* Part of ELIQUENT Life Sciences, a group of regulatory consultancies offering a broader array of services and expertise.
* Clients trust them for deep subject matter expertise and proven ability to deliver long-term results.
Additional information
Oriel STAT A MATRIX provides customizable, cost-effective training solutions for teams. They offer a 'buy three, get one free' enrollment for public training courses held on the same date and at the same location. This approach aims to boost efficiency and improve patient outcomes for their life science customers by helping them meet regulatory requirements. Their services are designed to assist manufacturers in understanding and complying with US FDA, EU, and international regulatory issues.
Key Highlights
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Founded in 1968, Oriel STAT A MATRIX is the oldest quality improvement training and consulting firm in the US.
Source
“Founded in 1968, Oriel STAT A MATRIX is the oldest quality improvement training and consulting firm in the US.”
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Specializes in medical device compliance, AI governance, and regulatory transitions like QMSR and EU AI Act.
Source
“They specialize in medical device compliance, AI governance, and regulatory transitions like QMSR and EU AI Act.”
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Offers a 'fourth enrollment free' promotion for public training courses when three students enroll at the regular price.
Source
“Enroll three students in the same course (held on the same date and at the same location) at the regular price and receive a fourth enrollment for free*.”
Certifications & Trust Signals
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Established in 1968, providing decades of experience in quality improvement and consulting.
Source
“Founded in 1968, Oriel STAT A MATRIX is the oldest quality improvement training and consulting firm in the US.”
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Operates under the ELIQUENT Life Sciences brand, a union of multiple life sciences regulatory consultancies.
Source
“All six companies have united under the ELIQUENT Life Sciences brand and offer our clients an even broader array of services and a deeper pool of expertise.”
Buyer Snapshot
Best for
- Life sciences companies seeking QA/RA consulting, auditing, and training.
- Organizations needing to comply with EU MDR, FDA regulations, and ISO standards.
How engagement typically works
- Consulting and auditing services.
- Public and customizable team training courses.
Typical deliverables
- Compliance gap analyses.
- SOP training and development.
- Auditing reports.
- Regulatory strategy guidance.
Good to know
- Best when requiring specialized expertise in medical device, IVD, and combination product regulations.
Pricing
Model:
Per project
HQ:
Washington, US
Languages:
English
Timezones:
America/New_York
Status:
listed
Services & Capabilities
Importer & Distributor Compliance Support
Jurisdictions:
EU, US
Countries:
US, DE, FR, NL, BE
Industries:
Medical devices, Healthcare, Distribution
Portfolio:
6-25, 26-100
Onboarding time:
6–17 days
Pricing model:
Per project
Starting from:
USD 950
Included services:
Training for economic operator obligations, Compliance gap scan, Audit readiness support
Training Available:
Yes
Template Pack Available:
Yes
Deliverables:
SOPs, Training
Training Format:
Both
Role Coverage:
Importer
Additional importer_distributor_compliance Details
Role Coverage
importer, distributor, Importer, Distributor
Supports MDR
Yes
Supports IVDR
Not explicitly stated, but implied through life sciences focus.
Verification Support
Yes
Device Classes Supported
Not explicitly stated, but implied through EU MDR and FDA support.
Storage Conditions Support
Not explicitly stated.
Onboarding Steps
Not explicitly stated, but implies a process of providing details for follow-up and proposal.
