Quality Management

IQVIA is a global leader in advanced analytics, technology solutions, and clinical research services for the life sciences industry. With a mission to accelerate innovation for a healthier world and a vision to power smarter healthcare for everyone, everywhere, IQVIA leverages unparalleled data, transformative technology, and deep healthcare expertise to drive better patient outcomes. Operating in over 100 countries with approximately 88,000 employees, IQVIA supports pharmaceutical, biotech, medtech, public health, and government organizations with a comprehensive portfolio of services and solutions. The company is recognized for its Connected Intelligence™, healthcare-grade AI, and commitment to sustainability, innovation, and evidence-based insights that shape the future of healthcare globally. IQVIA is also dedicated to reducing health inequities and driving sustainable change through innovation, collaboration, and data-driven solutions, partnering with organizations worldwide to address complex healthcare challenges.

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.

ATCC is a nonprofit biological resource center, with a nearly century-long legacy supporting public health, biodefense, and global health security. ATCC provides critical infrastructure for infectious disease research and CBR threat response. Our biorepository operations support federal agencies, academia, and industry through secure specimen handling, reagent authentication, and global distribution. ATCC manages over 22 million vials under federal contracts, including repositories for NIAID, CDC, BARDA, NCI, FDA, and USDA. These programs enable rapid deployment of validated biological materials for vaccine development, diagnostic assay verification, and therapeutic screening against high-consequence pathogens such as SARS-CoV-2. Certified under ISO 9001, 13485, 17025, and 17034, ATCC ensures quality, traceability, and regulatory compliance across its operations. Our high-containment laboratories (BSL-2 and BSL-3, with access to BSL-4 through partners) and Select Agent license position us to support MTEC-aligned efforts in emerging infectious diseases and medical countermeasure development for CBRN threats.

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.

From Rapid Innovation to Breakthrough Impact, Bessel Helps Startups and Scaling Teams Move Faster, Smarter, and Together with Fewer Missteps. Experience Bessel Rapid Innovation: We embed with your team to rescue stalled projects or fill critical gaps. From R&D to Quality Systems to Regulatory Affairs, we drive rapid progress to reduce your burn rate and improve profitability. We help your team deliver measurable results: reduced COGS, decreased complaints, improved performance. Our Powered by Bessel™ Accelerator is an Intensive, fixed-duration programs to refine your technology strategy, align teams, and prepare for fundraising—perfect for startups seeking clarity and velocity. Save months in development, find your sweet spot with investors, build and support your team. The Bessel Origin™ workforce development program, born in the classroom, trains emerging medtech teams in design thinking and agile teamwork, fueling innovation. Boost team performance and identify, develop, and retain your emerging leaders.

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.

Harmac is a global contract design and manufacturing organization specializing in single-use medical devices. With over four decades of experience, Harmac provides comprehensive services including product design and development, advanced manufacturing, automation, value engineering, quality assurance, and packaging and sterilization. The company is known for its operational excellence, regulatory compliance, and commitment to sustainability and community engagement. Harmac operates facilities across the United States, Ireland, and Mexico, supporting customers worldwide and across a range of clinical applications. ISO 13485 Certified and FDA Registered.

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.

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.

Ease Healthcare (a registered DBA of MPS Medical, Inc.) is committed to advancing next-generation military medicine by accelerating access to clinically validated diagnostic tools, monitoring devices, and health and wellness technologies. As a trusted commercialization partner and distributor, the company empowers providers, organizations, and individuals with advanced solutions that support early detection, timely intervention, and improved health outcomes in both civilian and military settings. With a mission to make cutting-edge science and technology accessible to all, Ease Healthcare focuses on addressing critical health challenges such as 02 delivery, cancer, and cardiovascular disease —areas that directly impact force readiness and resilience. The company’s vision is to break barriers in healthcare by delivering innovative medical solutions that are affordable, accessible, and simple to use, regardless of economic or geographic limitations. In addition to bringing transformative technologies to market, Ease Healthcare provides turnkey services for medical device manufacturing and distribution, guiding partners from product development through regulatory compliance and successful deployment. By combining technical expertise with a dedication to accessibility, Ease Healthcare supports the Department of Defense’s priorities in preparing and protecting service members with next-generation healthcare solutions.

Intellisense Systems, Inc. develops and manufactures advanced technologies that modernize armed forces and support commercial and government operations through innovative defense electronics, avionics displays, and environmental monitoring systems. The company specializes in replacing obsolete electronic systems, providing rugged, modular, and autonomous solutions for weather monitoring, avionics displays, power management, and more. With a strong focus on quality, innovation, and mission-readiness, Intellisense serves military, commercial, and government clients, delivering products that enhance operational efficiency, safety, and situational awareness in the most demanding environments. Their solutions are designed for compatibility with legacy systems and open architectures for future upgrades, ensuring long-term value and reduced lifecycle costs. Intellisense's Micro Weather Station (MWS) series is deployed in over 60 countries and on all 7 continents, and the company is recognized for its rapid innovation, including the development of the world's smallest lidar ceilometer and advanced power distribution solutions.

Exponent is a multidisciplinary science and engineering consulting firm serving sectors including healthcare, energy, manufacturing, and consumer products. From medical devices, pharmaceuticals, and supplements to digital health and wearables, we deliver rigorous science that quantifies impacts on human health. Exponent helps you push the envelope on the development, deployment, safety, and effectiveness of cutting-edge drugs, devices, and diagnostics — concomitantly balancing benefits and risks. Count on our multidisciplinary, data-driven, evidence-based assessments to give you clarity on your most complex product needs and challenges. With lives on the line, innovations that support healthcare demand the highest levels of scientific rigor. Whether you’re developing a novel drug, a sturdier stent, or a faster flu test, you need clear answers to complex questions, quickly. Exponent supports our life sciences clients across the total product lifecycle by solving critical design, regulatory, safety, and market access challenges. We can collaborate with you throughout your journey, helping you navigate risks and opportunities — and optimize outcomes — with science-based strategies and specialized expertise.

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.

Simbex is a leading partner in medical device and consumer health product design and development, recognized for transforming complex ideas into commercially successful solutions. With a multidisciplinary team, Simbex excels in engineering, product design, software, data analytics, and commercialization strategy, supporting innovators from concept to market. Their mission is to deliver impactful medical devices and consumer health products that improve health outcomes and quality of life. Simbex is known for its holistic approach, deep regulatory expertise, and commitment to innovation and excellence in the health technology sector. The company is also active in thought leadership, regularly publishing regulatory and reimbursement updates, and hosting educational webinars for the MedTech community. Simbex maintains a robust Quality Management System compliant with ISO 13485 and FDA 21 CFR 820, ensuring high standards in product development. The company is also committed to supporting diversity in MedTech, including initiatives for women in the sector. Simbex's leadership and advisory team bring decades of experience in biomedical engineering, commercialization, regulatory affairs, and technology innovation, further strengthening its position as a trusted partner in the MedTech ecosystem.