Quality Management

The Advanced Regenerative Manufacturing Institute (ARMI) is a member-based, nonprofit organization dedicated to advancing the bioeconomy of the United States. Its mission encompasses enhancing manufacturing, healthcare, and education and workforce development, aiming to create a scalable and effective manufacturing ecosystem for engineered cells, tissues, and organs.

Nanohmics Inc. is a Texas-based research and development company founded in 2002, specializing in the applied sciences of light, molecule, and advanced material interactions. The company focuses on designing and developing smart technology solutions that enhance product, technology, or system performance across various industries. With a multidisciplinary team of scientists and engineers, Nanohmics integrates advanced materials and state-of-the-art instrumentation engineering to create custom-engineered sensing technologies and platforms. Their mission is to accelerate client success through innovative product development, providing solutions for detection, surveillance, electro-optic imaging, performance characterization, environment awareness, and energy conversion applications.

Omnica Corporation is dedicated to advancing the medical device industry through innovative design and engineering solutions. With nearly four decades of experience, the company specializes in rapid medical device development, providing comprehensive services that include prototyping, verification, and validation. Omnica's commitment to quality and customer satisfaction is reflected in its high rate of repeat business and long-term client relationships.

ERP International is a trusted provider of health and technology solutions, specializing in serving federal civilian and defense agencies. Founded in 2006, the company focuses on enhancing mission performance through innovative staffing, technology solutions, and business process management, all while maintaining a commitment to excellence and community engagement.

Tanner Research, Inc., founded in 1988, specializes in advanced electronics, micro-electro-mechanical systems (MEMS), mechanical designs, software, and autonomous robots. The company is committed to innovation and technology, aiming to solve challenging problems for clients in government, industry, and academia. With a focus on R&D, Tanner Research pushes the limits of technology to deliver unprecedented capabilities in various domains.

ATCC (American Type Culture Collection) is a nonprofit, global, biological resource center and standards organization. It is the leading developer and supplier of authenticated cell lines and microorganisms, leveraging its rich history and knowledge to provide essential products, services, and resources for critical life science research. ATCC is also recognized as a Great Place To Work Certified™ company, emphasizing a collaborative, diverse, and innovative culture that supports scientific advancement and global health protection.

Persistent Technology, Inc. (PTI) is dedicated to delivering transformative, human-centered solutions that improve patient care. With a focus on digital transformation and emerging technologies, PTI offers innovative solutions that enhance user adoption, improve data quality, and foster interoperability. The company is committed to supporting military and veterans' health, leveraging its expertise to provide cutting-edge healthcare technology solutions.

Bessel's mission is to deliver breakthroughs that scale by empowering medtech startups and teams. Bessel provides comprehensive strategy, execution, and fundraising support from initial concept to commercial release. The company is committed to fostering innovation and high-performance teams through its various programs, including the Powered by Bessel accelerator, Bessel Origin learning laboratory, and Bessel Rapid Innovation consulting services.

Booz Allen Hamilton is a leading management and technology consulting firm with over 110 years of experience. The company is dedicated to empowering people to change the world through innovative solutions in various sectors including cybersecurity, artificial intelligence, engineering, and defense. Booz Allen partners with government and commercial clients to tackle their most complex challenges, leveraging a culture of innovation and a commitment to excellence. The firm operates with core values of integrity, courage, service, ingenuity, and a commitment to diversity and inclusion.

Clinical Research Strategies (CRS) is a Pittsburgh-based contract research organization and executive management consultancy dedicated to improving the performance of start-up and mid-size life sciences companies. With a focus on instilling fiscal discipline and reducing risks in clinical development, corporate affairs, and quality assurance programs, CRS provides tailored consulting and staffing solutions to navigate the complexities of regulatory pathways and ensure successful product launches. CRS is also committed to leveraging advancements in artificial intelligence and machine learning to enhance clinical research and regulatory processes.

Jaunt LLC is a management consulting firm specializing in the MedTech sector. They empower executives and entrepreneurs by providing market intelligence, strategic guidance, and product management expertise to navigate the complexities of medical technology commercialization. Their mission is to help clients confidently advance their innovations and achieve market success through informed decision-making and strategic partnerships.

Glacier Support Services, LLC (GSS) is an 8(a) small disadvantaged business and Alaska Native Corporation (ANC) that provides a range of services including Healthcare Services, Research & Development, Public Health, Information Technology, and Facilities Support. GSS is committed to exceeding customer expectations while maintaining high standards of service and flexibility to meet the changing needs of clients.

DLH delivers improved health and national security readiness solutions for federal programs through science research and development, systems engineering and integration, and digital transformation. With over 3,200 employees, DLH is committed to solving complex problems faced by civilian and military customers, leveraging advanced technologies and methodologies to enhance health outcomes and operational readiness.

Tietronix Software, Inc. is a minority-owned small business founded in 1999, located in Houston, Texas, near NASA Johnson Space Center. The company specializes in providing innovative software solutions and services across various sectors including medical, aerospace, and renewable energy. Tietronix is committed to high quality, reliability, and customer satisfaction, leveraging a diverse workforce and a strong project management team to deliver complex, mission-critical systems.

EmergingDx is dedicated to inventing, developing, and commercializing emerging technologies and products aimed at improving the quality of the human condition while positively impacting the environment and society. The company comprises a diverse team of world-class scientists, engineers, product designers, and business leaders with a proven track record of innovation and successful technology transition.

MicroHealth, LLC is a veteran-owned small business specializing in comprehensive IT solutions for federal agencies. With a focus on healthcare IT, the company provides services such as agile project management, cybersecurity, software development, and data analytics, ensuring operational efficiency and compliance across diverse industries. MicroHealth is dedicated to enhancing healthcare delivery through innovative technology solutions, including telehealth services and electronic health records. The company also excels in health informatics support, providing tailored solutions for data management and clinical decision-making. MicroHealth is committed to fostering an inclusive workplace and actively seeks to hire veterans, recognizing their unique skills and dedication.

PPD, a clinical research business of Thermo Fisher Scientific, is a leading provider of global contract research organization (CRO) solutions. The company is dedicated to helping clients accelerate the development of life-changing therapies through comprehensive drug development, laboratory, and lifecycle services. With a commitment to operational excellence and innovative technology, PPD empowers its customers to bring therapies to market faster and improve patient health. PPD has been recognized as an industry leader in clinical development digital transformation services and patient engagement digital transformation. With over 30 years of clinical leadership and a workforce of more than 30,000 employees globally, PPD has conducted over 2,100 trials in the past five years.

PSC Biotech is a leading life science consulting firm that specializes in providing comprehensive solutions to highly regulated industries. With over 25 years of experience, PSC Biotech focuses on ensuring compliance, enhancing operational efficiency, and delivering high-quality consulting services tailored to the unique needs of clients in the pharmaceutical, biotechnology, and medical device sectors. The company operates in 52 countries globally and has served thousands of clients, employing a global team of skilled professionals and experts. PSC Biotech is committed to elevating quality management systems and ensuring data integrity through innovative solutions and partnerships.

Solventum is a healthcare company dedicated to enabling better, smarter, and safer healthcare solutions. With a legacy of innovation, Solventum focuses on improving patient outcomes through advanced medical technologies, oral care solutions, health information technology, and purification and filtration systems.

JAKTOOL is a premier product development, engineering, and precision prototyping company based in Cranbury, NJ. With over 25 years of experience, JAKTOOL specializes in delivering high-quality turnkey engineering solutions for heavily regulated industries, including medical technologies, military, and aerospace. The company is committed to innovation, quality, and customer satisfaction, providing a collaborative environment that fosters personal and professional growth.

Terumo Blood and Cell Technologies is a global leader in medical technology, specializing in blood and cell-based therapies. With over 7,900 team members, the company is dedicated to advancing healthcare by providing innovative solutions for blood collection, processing, and storage. Their mission is to empower healthcare providers with the tools and insights needed to deliver high-quality care to patients worldwide. Terumo BCT is committed to unlocking the potential of blood and cells, offering a range of products and services that support lifesaving transfusions and next-generation therapies for diseases like cancer. The company is part of the Terumo Group, which has been contributing to society through healthcare for over a century.

Alira Health is a global consulting and clinical services company that aims to humanize healthcare and life sciences through innovative technologies and expert guidance. They focus on improving patient outcomes by integrating patient voices into the development of treatments and enhancing care quality across the healthcare ecosystem.

Hatch PD specializes in product design and development, offering a comprehensive range of services from concept to consumer. With a focus on innovation, efficiency, and quality, Hatch collaborates with clients to transform ideas into market-ready products while ensuring seamless integration of design and manufacturing processes. Their all-in-one approach integrates hardware, software, and firmware development, reducing time to market and enhancing product quality.

Southwest Research Institute (SwRI) is a nonprofit research and development organization that provides independent, premier services to government and industry clients. Founded in 1947, SwRI is committed to advancing science and technology to benefit humanity, focusing on innovative solutions that improve human health and safety. With a diverse range of technical divisions, SwRI addresses complex challenges in various fields including mechanical engineering, materials, aerospace, automotive, biomedical, and more.

The SPECTRUM Group is a premier strategic advisory and government relations firm with over 29 years of experience. They provide expertise in federal and commercial markets, helping clients develop effective solutions across various sectors including defense, security, healthcare, and energy. Their mission is to deliver successful client outcomes through experience, expertise, and integrity.

Goldbelt Apex is a health information technology company dedicated to creating interoperable data ecosystems that drive better models of care. Founded in 2021, it is a subsidiary of Goldbelt, Inc., an Alaska Native Corporation, and focuses on delivering high-quality healthcare interoperability solutions through innovation and proven methodologies.

BioBridge Global is a nonprofit organization dedicated to saving and enhancing lives through the healing power of human cells and tissue. It operates a family of nonprofits including South Texas Blood & Tissue, QualTex Laboratories, GenCure, and The Blood & Tissue Center Foundation. The organization provides lifesaving therapies to patients and supports advances in advanced therapies, focusing on blood, cell, and tissue products, testing services, and the development of new therapies.

CSSi LifeSciences is a global, innovative regulatory consulting group specializing in advancing therapeutics and medical devices through development and regulatory approval. The company offers customized solutions that mitigate risk, time, and expense to support the U.S. market goals of its clients, ensuring a clear and actionable pathway to successful commercialization.

Greenlight Guru is dedicated to improving the quality of life for patients and customers by providing innovative software solutions tailored for the medical device industry. Their mission is to help MedTech companies navigate the complexities of product development, regulatory compliance, and quality management, ultimately accelerating the delivery of life-changing technologies to market. With a commitment to quality and security, Greenlight Guru is ISO 9001 and ISO 27001 certified, ensuring high standards in their operations.

Strategic Marketing Innovations, Inc. (SMI) is a government affairs firm based in Washington D.C. with over 30 years of experience in helping technology companies secure federal funding. SMI specializes in navigating the complexities of government funding processes, connecting clients with decision-makers, and advocating for policies that benefit their interests across various sectors including defense, energy, life sciences, and advanced materials.

ECS is a leading provider of advanced technology solutions, specializing in cloud, cybersecurity, artificial intelligence, machine learning, and enterprise transformation. With a commitment to delivering innovative solutions, ECS partners with government agencies and commercial enterprises to enhance operational efficiency and drive mission success. ECS has also established itself in environmental science and unmanned aviation, showcasing its versatility in addressing complex challenges. The company is dedicated to ethical AI practices and has a strong focus on diversity, equity, and inclusion within its workforce.

Design West Technologies (DWT) is a nontraditional defense contractor founded in 1994, dedicated to providing innovative engineering solutions for warfighters. With nearly 30 years of experience, DWT specializes in weapon systems and CBRN (Chemical, Biological, Radiological, and Nuclear) detection and protection, operating from a facility in Southern California that is AS9100D/ISO 9001-2015 and ITAR certified.

Viscus Biologics LLC specializes in product realization from ideation to high volume production, manufacturing components, devices, and products with natural polymer and extracellular matrix materials. The company aims to fulfill patient and market needs, improve quality of life, and restore tissue to a healthy state.

Leidos is a leading systems integrator in science, technology, and engineering, dedicated to solving some of the world's toughest challenges. The company emphasizes a commitment to integrity, diversity, and sustainability while delivering innovative solutions across various sectors including defense, healthcare, and energy.

The Military & Health Research Foundation is a non-profit organization dedicated to advancing military technology and medical research. It serves as a communication bridge between innovative researchers and funding sources, focusing on delivering effective solutions for medical capability gaps. The foundation fosters collaboration among industry, academia, and military entities to enhance healthcare for American military personnel.

Osetomics focuses on developing diagnostic and prognostic tools aimed at treating acute musculoskeletal injuries, chronic orthopedic pathologies, and complications related to bone implants. The company is part of the PCI Ventures initiative, which supports the commercialization of innovative technologies from the University of Pennsylvania.

RTI International is an independent nonprofit research institute dedicated to improving the human condition. With a vision to address the world's most critical problems through science-based solutions, RTI integrates expertise across social and laboratory sciences, engineering, and international development to deliver reliable data, thorough analysis, and innovative methods that inform public policy and practice.

MassBiologics, part of UMass Chan Medical School, is the only nonprofit, FDA-licensed manufacturer of vaccines and biologics in the United States. With over 100 years of experience, it is dedicated to improving public health through the research, development, and production of biologic products, including vaccines and monoclonal antibodies.

NCS Technologies is a computer manufacturer and specialized systems integrator that provides tailored technology solutions to meet the unique requirements of its customers. Founded in 1996, the company has evolved to deliver a broad array of value-added services and turnkey solutions optimized for innovation and flexibility, serving a global customer base.

BioTechnique® is a full-service Contract Research Development and Manufacturing Organization (CRDMO) specializing in sterile injectable fill-finish services. With a commitment to quality and innovation, BioTechnique® aims to enhance healthcare outcomes worldwide by providing high-quality life-saving products and maintaining the highest standards in pharmaceutical manufacturing.

SoarTech is an industry leader in the application of innovative, context-informed AI solutions for Department of Defense (DoD) research and development problems. The company focuses on developing intelligent software that reasons like humans, automating complex tasks, simplifying human-machine interactions, and modeling human behaviors. SoarTech emphasizes a human-centered approach to AI, aiming to enhance human capabilities rather than replace them, and is committed to transparency and explainability in AI systems.

Founded in 2007, Knowesis is a Woman Owned Small Business that provides innovative solutions to the Federal Government, specializing in Military and Veterans Health, Emergency Response, Diversity, Equity, and Inclusion, and more. With a commitment to harnessing data to predict health outcomes, Knowesis aims to enhance the effectiveness and efficiency of government programs through its diverse expertise and strategic partnerships.

Oak Grove Technologies is a leading provider of training and technical solutions with over 20 years of experience. The company specializes in multi-domain training, blended learning products, and intelligence services, serving clients across various sectors including the Department of Defense, government agencies, and commercial organizations. Founded by a former Army Soldier, Oak Grove is committed to empowering veterans and delivering high-quality services that meet the needs of its clients.

MRIGlobal is a renowned Midwest research institute based in Kansas City, dedicated to improving the overall health, safety, and well-being of people everywhere. With over 80 years of experience, MRIGlobal specializes in diagnostics, pharmaceutical sciences, vaccines and therapeutics, global health surveillance, infectious disease, public health, warfighter protection, agriculture, and management and operations. The organization is committed to using science and technology to create solutions for a safer, healthier, and more sustainable world.

The Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF) is dedicated to advancing military medicine through research and innovation. For over 40 years, HJF has been a trusted partner in managing research awards, ensuring compliance, and facilitating the transition of medical innovations from concept to commercialization. The foundation supports a wide range of research areas, including infectious diseases, cancer, and mental health, with a focus on improving the health and readiness of military personnel and civilians alike.

RQMIS (Regulatory/Quality Management Information Source) is a global regulatory consultancy dedicated to guiding medical device, pharmaceutical, nutraceutical, and cosmetic companies through the complex pathways of product development, regulatory approval, and market sustainability. Established in 1996, RQMIS operates from strategic locations in Amesbury, Massachusetts (USA); Barcelona, Spain; and London, United Kingdom, enabling comprehensive support for clients worldwide. RQMIS emphasizes personalized service, ensuring accessibility and responsiveness to client needs. The firm's mission is straightforward: to bring clients' products to market efficiently and maintain their success through ongoing compliance and strategic support.

TensorX represents the digital transformation of the enterprise, leveraging the Cloud, the Crowd, and AI to inform strategy, drive innovation, and optimize performance. Their unique approach creates a Machine of Machines℠ that provides Intelligence as a Service℠ (IaaS), enabling clients to focus on high-impact opportunities and continuously optimize business performance.

Chenega Reliable Services, LLC (CRS) is a staffing company and wholly-owned subsidiary of Chenega Corporation, an Alaska Native Corporation. CRS provides full-service environmental consulting services, environmental remediation services, construction, facilities and logistics support services, healthcare staffing, research and development, training, and staff augmentation. The company is ISO 9001:2015-certified and headquartered in San Antonio, Texas, emphasizing a commitment to high-quality service and compliance with federal standards. CRS offers flexible and streamlined 8(a) Direct Award procurement options to federal customers, providing an accelerated procurement timeline and agile contracting solutions.

Rhythmlink International, LLC is a leader in the design, manufacture, and distribution of medical devices, specializing in neurodiagnostic equipment. Founded in 2002, the company is dedicated to improving patient care through innovative solutions and superior customer service, ensuring consistent availability and fair pricing.

DesignPlex Biomedical specializes in the prototyping, design development, and contract manufacturing of medical devices. The company is dedicated to improving patient outcomes through innovative medical solutions, focusing on quality and collaboration with clients to bring their ideas to life.

VitaCyte specializes in the manufacture and supply of GMP Grade purified-defined collagenase and protease enzymes for cell and tissue dissociation. The company is dedicated to supporting researchers, commercial cell suppliers, and institutions involved in cell therapy and transplantation, providing high-quality products that enhance the efficiency and effectiveness of cell isolation processes. VitaCyte is committed to improving the science of cell recovery and has a history of innovative solutions in the field of cell isolation, contributing to significant advancements such as the Edmonton Protocol for islet transplantation. Their products, particularly the purified-defined collagenase, ensure high lot-to-lot consistency and rigorous enzyme characterization, setting a standard in the industry.

nou Systems is dedicated to transforming defense systems through innovative, mission-driven technology. With expertise in systems engineering, modeling and simulation, and real-time open systems development, the company delivers powerful, data-driven insights that enhance system capabilities across various complex defense systems.

Medtrade is a global medical device company based in the UK, dedicated to saving and improving lives through innovative solutions in wound care, trauma, and hemostasis. With a focus on tackling global health challenges, Medtrade provides advanced manufacturing, regulatory, and marketing support to distribution partners worldwide.

Reed Integration, Inc. is a woman-owned small business that specializes in providing innovative consulting and training services to federal and commercial clients. With over two decades of experience, the company focuses on delivering superior business results through a unique combination of expertise in systems engineering, project management, and advanced analytics. Their mission is to ensure client success while enriching the lives of their team and the communities they serve.

Matregenix is a global leader in nanofiber technology, specializing in highly customizable nanofibrous materials for diverse applications, particularly in filtration and biomedical fields. The company is committed to pushing the boundaries of nanofiber technology through innovative platforms and state-of-the-art electrospinning machines, providing comprehensive contract development and manufacturing services to help manufacturers bring their innovations to market.

Proxima Clinical Research, Inc. (Proxima CRO) is a leading Contract Research Organization (CRO) that specializes in providing innovative solutions for medical devices, drugs, and diagnostics. With a focus on agility and efficiency, Proxima aims to de-risk biotech and MedTech programs, enhance regulatory clearance chances, and optimize capital efficiency. The company is dedicated to supporting clients through every stage of clinical development, ensuring timely and cost-effective results.