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.

BioPharma Connections is an independent, woman-owned consulting firm founded in San Francisco in 2007, providing strategic business development, technical operations, regulatory, product development, and commercialization support to the life sciences industry. Serving pharmaceutical, biotechnology, medical device, and diagnostic companies globally, the firm specializes in facilitating connections between organizations, service providers, CROs, CDMOs, and investors—guiding clients from concept to commercialization, with deep expertise in regulatory compliance, emerging technologies, and diverse therapeutic areas.

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.

Revolution Biomanufacturing Inc. (RBIx) is expanding beyond traditional CDMO Process/Analytical Development and Manufacturing services to pioneer distributed molecular manufacturing. A new class of digital biomanufacturing that enables the autonomous design, manufacture, quality verification, and deployment of Nucleic Acid therapeutics and molecular diagnostics at the point of need. By integrating AI-driven sequence optimization, enzymatic nucleic acid synthesis, Nanoparticle design and manufacturing (LNP & EV), closed-loop quality control, and field-deployable manufacturing platforms, RBIx is creating adaptive biological infrastructure capable of responding to emerging diseases, national security threats, and personalized medicine with unprecedented speed and flexibility.

Bessel helps medtech startups and scaling teams move faster with hands-on support across R&D, marketing, quality, regulatory readiness, product development, manufacturing transfer, commercialization, fundraising readiness, and high-performance team execution. From Rapid Innovation to Breakthrough Impact, Bessel helps startups and commercially scaling teams build better and deliver faster with Bessel's AI Teammate for high-performance blended human + AI teams. 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 program 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.

Telesair, Inc. develops, engineers, and manufactures non-invasive respiratory care devices focused on high flow oxygen therapy for hospital and long-term care. Their technology integrates real-time sensor monitoring, automated alarm and safety systems, and user interface solutions. The company adheres to global regulatory standards, quality assurance, and infection control protocols to support safe, effective respiratory therapy for both adults and children.

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.