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Certifications

MRIGlobal maintains all necessary licenses and certifications to conduct safe, defensible studies on a host of diverse materials, from pharmaceuticals and explosives to chemical and biological agents.

International Organization for Standardization (ISO)

BSI Management Systems, an International Organization for Standardization (ISO) registrar, has granted ISO 9001:2015 certification to most MRIGlobal physical locations operating under our quality management system (Headquarters, North Kansas City, Charlottesville, and Gaithersburg). This certification recognizes MRIGlobal’s ability to consistently provide products and services that meet client and applicable regulatory requirements.

Our Gaithersburg facility is also ISO 17025 accredited and the Kansas City Facilities have both CLIA and soon  ISO 17025 accredited laboratory space.

Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP)

The FDA, EPA, and numerous clients have found MRIGlobal compliant with regulations governing GLP (FDA, EPA-FIFRA, EPA-TSCA) and GMP.

Food and Drug Administration (FDA)

Drug Establishment Registration

Drug Master File

Environmental Protection Agency (EPA)

FIFRA Establishment

 

United States Department of Agriculture (USDA)

For all species except rats and mice


Public Health Service (PHS) Animal Welfare Assurance

For PHS funding only

Human Subjects:  Office for Human Research Protection (OHRP)

Nuclear Regulatory Commission (NRC)


Drug Enforcement Administration (DEA)—Controlled Substance Registration

Schedules 1-5

Centers for Disease Control and Prevention (CDC)

Facility Registration for Transferring or Receiving Select Agents

CBRNE/CWMD Chemical Agent Operations

Provisioning Agreement

USDA Animal and Plant Health Inspection Services (APHIS)

Multiple permits for select agents and toxins

Centers for Medicare and Medicaid Services (CMS)

Clinical Laboratory Improvement Act/Amendment (CLIA)

College of American Pathologists (CAP)

Full accreditation


Florida—Agency for Health Care Administration (AHCA)


ATF Explosive Materials Permit

> 70 staff with possessor licenses

 

Defense Security Service (DSS)

NISPOM Accredited


Methods

CBRNE Tech Index scientists at MRIGlobal frequently perform standardized and custom evaluations for a wide range of customers. Evaluation methods can range from those requiring published MIL-STD, ASTM, or EPA regulatory compliance testing, to highly customized set-ups and target lists for unique clients. As part of any testing and evaluation program, MRIGlobal will deliver a detailed test plan for approval by the client long before actual testing begins. Test plans contain detailed test matrices, references to applicable ASTM, EPA, and other nationally recognized methods, leverage existing internal methods and SOPs, and help walk our clients through the entire evaluation process at the level of detail desired. Many clients wish to have in-depth step-by-step procedures to be witnessed at all times by multiple staff, others simply wish to have an overview of the general methods and schedules. 

The less thought of, yet typically most important, piece of the puzzle is often the human factors portion of an evaluation. Our diverse staff includes a variety of skill, education, and experience levels that all uniquely contribute to a product evaluation by providing specific end-user viewpoints. Through our many years of experience, we have both internal and external contacts in virtually all areas of CBRNE equipment ranging from local first responders and crime laboratories to military personnel and federal agents.


Coronavirus evacuees return safely to U.S. via innovative, MRIGlobal-designed biocontainment system.

Fourteen U.S. citizens who tested positive for coronavirus are receiving medical treatment back home in the U.S. yesterday – and not thousands of miles away in Japan – partly in thanks to innovative technology by biocontainment and global health experts at MRIGlobal, based in Kansas City, Missouri.

As reported on international news, the citizens were evacuated on Monday from the Diamond Princess cruise ship, which had been quarantined off the coast of Japan for more than 10 days. The patients were evacuated in the safest manner to a specialized containment area on chartered evacuation aircraft to isolate them, using standard protocols, for medical care in coronavirus treatment centers in the U.S.

One of the specialized units was designed by MRIGlobal engineers through a private-public partnership with U.S. Department of State and the Paul Allen Foundation in response to the Ebola outbreak in 2014. The units are state-of-the-art, flight-ready containerized biocontainment systems (CBCS) that roll on and off planes. MRIGlobal designed the CBCS as a reusable bio-containment and medical treatment unit to operate on government/civilian cargo aircraft. The units can containerize highly contagious pathogens, are extremely durable and allow for the safe transport of critically ill patients while maintaining biocontainment and safe flight.

According to Dean Gray, Ph.D., Director at MRIGlobal, “We’re proud to play a part in helping to safely evacuate people out of harm’s way to locations where they can receive appropriate medical care.

“There’s nothing like the CBCS for flyable medical transport” added Gray. “It was developed to respond to critical global health situations like the coronavirus outbreak, and ultimately to save lives.”

To date, MRIGlobal has designed and delivered four CBCS units, which are in use by the U.S. government.

MRIGlobal’s state-of-the-art, flight-ready Containerized Biocontainment System (CBCS) was awarded an R&D100 Award for Innovation by R&D Magazine in 2016. Each year R&D Magazine presents the awards to 100 of the most technologically significant and innovative technologies introduced to the marketplace over the past year.

TO LEARN MORE, VISIT THE SITES BELOW:
  • For more information about CBCS, visit https://mriglobal.org/containerized-bio-containment-system-cbcs/
  • Outside media sources covering this event –
    – https://www.thedrive.com/the-war-zone/32248/747s-carrying-americans-exposed-to-coronavirus-used-new-quarantine-box-for-infected-flyers
    – http:www.businessinsider.com/coronavirus-japan-cruise-passengers-isolated-plane-2020-2?fbclid=IwAR322KLoEJhI4W-6BF5VfZItQDCoJDw7VoxxcoiYZhRYI-_2m1YGvn-VCh8