Regulatory

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.

Deloitte is a leading global provider of audit, consulting, tax, and advisory services. The company is committed to improving public outcomes through a focus on people and developing relevant, timely, and sustainable solutions for clients. Deloitte's mission is to lead with purpose and drive positive change for people and communities, with a strong emphasis on social impact, sustainability, equity, and trust. Deloitte is also dedicated to helping the power, utilities, and renewables industry grow to become more sustainable, safe, and efficient, and is a fierce champion of industrials, inspiring optimism for the future.

The Conafay Group specializes in representing life sciences companies, universities, and other organizations in the biomedical space before the federal government and associated stakeholders. Since 2004, they have been helping clients advance their research and policy goals by leveraging federal government resources and building strong coalitions.

LaCire is a consulting firm dedicated to empowering innovators, changemakers, and organizations by providing expert-level operations, human capital management, and business development services. With a mission to maximize the power of the innovator, LaCire helps clients build strong foundations for sustainable growth, focusing on ethical standards, flexibility, and collaboration. The company specializes in supporting women- and minority-owned businesses, nonprofits, startups, and international organizations seeking to establish or expand their presence in the U.S. LaCire's experienced team offers tailored solutions in operations, finance, government contracting, communications, and more, enabling clients to achieve authentic, long-term success.

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.

PinMed, Inc., is a National Innovation Award-winning bioinformatics/medical-device company that develops high-fidelity cardiovascular monitoring systems, personalized (adaptive) software, and integrated systems and custom solutions for tracking cardiovascular data in the most challenging environments (e.g., intensive activity, extreme electromagnetic interference, and interventional cardiovascular procedures) and identifying subtle but clinically important indicators of cardiovascular events. PinMed’s award-winning solutions include versatile, multisensor, high-fidelity monitoring systems for various hospital and ambulatory settings. The company has extensive experience in electronic and mechanical engineering, development of software and firmware for various processors, computational modeling, and cardiovascular physiology. PinMed’s flagship mobile platform, PELEX, provides unparalleled versatility in physiological monitoring and has been cleared by the FDA for diagnostic 12-lead ECG testing and various types of ambulatory monitoring.

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.

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.

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.

Kaléo is a global leader in drug-delivery device technology and auto-injector innovation, providing millions of patients with security and peace of mind. Our patented Aerio™ platform, with unmatched capabilities and human factors engineering, powers our portfolio of auto-injector products, as well as products under development for third parties.

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.

Martin, Blanck & Associates, LLC (MBA) is a healthcare consulting firm based in Alexandria, Virginia, founded in 1998 by Dr. Edward Martin and Mr. Alfred Giambone. The firm specializes in providing critical assistance to private sector clients, nonprofits, associations, and universities focused on federal healthcare delivery systems, public health programs, and government contracting. With over two dozen senior executive partners and more than 500 years of combined healthcare experience, MBA offers expertise in healthcare policy, program development, executive management, strategic planning, informatics, medical countermeasures, public health strategies, and emerging infectious diseases. The firm is committed to professionalism, ethical service, and delivering results for clients in both the public and private sectors.

Accenture is a global professional services company with extensive capabilities in strategy and consulting, digital transformation, technology, and operations. The company aims to drive innovation and efficiency across various industries, helping clients navigate complex challenges and seize opportunities in a rapidly changing environment. Accenture is committed to creating positive change around the world and ensuring responsible business leadership for its people, clients, and communities. The company emphasizes continuous learning, responsible AI practices, and a culture of belonging and diversity.

VETRUN LLC is intentionally structured as a lean, project-focused organization designed to deliver complex, regulated medical products with speed, accountability, and cost efficiency. Rather than maintaining large internal departments for legal, regulatory, testing, manufacturing, and specialized engineering functions, VETRUN utilizes a distributed execution model, contracting with best-in-class service providers as required by each program. VETRUN works exclusively on one project at a time, enabling full leadership focus, rapid decision-making, and disciplined execution without competing internal priorities. This model allows VETRUN to assemble a tailored team of subject matter experts for each program, including legal counsel, FDA regulatory consultants, accredited testing laboratories, industry experts, contract manufacturers, and design and development partners. These relationships are not ad hoc. VETRUN has curated a robust network of U.S.-based (“Made in USA”) companies over more than 20 years, selecting partners with demonstrated experience in FDA-regulated medical devices, government programs, and high-reliability manufacturing. This long-standing network enables VETRUN to rapidly mobilize proven resources, scale capabilities as needed, and replace or augment services without disruption. By avoiding fixed overhead associated with large permanent staff and facilities, VETRUN maintains low indirect costs while preserving access to deep technical and regulatory expertise. This structure enhances flexibility, reduces financial risk, and allows resources to be applied directly to execution and milestone achievement rather than administrative burden. This execution model results in a company that is fast-moving, adaptable, and highly responsive, well-suited for time-sensitive programs requiring regulatory rigor, domestic manufacturing, and close coordination with Government stakeholders. VETRUN’s role is to serve as the integrator and accountable authority, ensuring that all partners operate cohesively toward a common objective while maintaining schedule discipline, quality compliance, and mission focus.

Smith+Nephew is a portfolio medical technology company focused on the repair, regeneration, and replacement of soft and hard tissue. The company aims to restore people's bodies and their self-belief by using technology to take the limits off living. With a commitment to medical education and improving patient outcomes, Smith+Nephew operates in over 100 countries and is dedicated to sustainability and community health. Their purpose is to promote health and wellbeing, not just through their products but also by ensuring a positive impact on society and the environment. Smith+Nephew is also committed to increasing diversity within the medical device industry through initiatives like the Orthopaedics for All global advisory board.

Emmes is a global full-service clinical research organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation. With over 47 years of experience, Emmes has conducted more than 2,150 clinical trials across various therapeutic areas, including vaccines and infectious diseases, ophthalmology, neurology, rare diseases, and cell & gene therapies. The company leverages technology and AI to enhance clinical research efficiency and quality, aiming to improve patient outcomes and accelerate the delivery of new treatments.

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.

The University City Science Center (the Science Center) is a 501(c)3 non-profit organization based in Philadelphia, PA. The Science Center catalyzes innovation to maintain the technological superiority of the American military and the strength of the American economy. The Science Center’s core activities include programming to support and train entrepreneurs, commercialize dual use technologies, expand available capital for high growth firms, and cultivate the domestic STEM talent pipeline. We empower early-stage companies to secure and manage federal funding through specialized assistance. By leveraging our government relationships, providing comprehensive proposal development, and deploying sophisticated award management, the Science Center streamlines the process for startups in accessing federal funding. By ensuring that American scientific and technological innovations are rapidly advanced and integrated into defense and dual-use applications, the Science Center strengthens the US industrial base, enhances military readiness, and safeguards national security interests. This lab-to-market pipeline is critical to maintaining technological overmatch, securing supply chain resilience, and reinforcing biosecurity infrastructure. The Science Center’s innovation acceleration initiatives can directly contribute to the Department of Defense’s modernization priorities by reducing reliance on foreign technologies, fostering high-growth industries in critical technology areas, and ensuring that STEM advancements serve as strategic assets to protect and advance US interests. Since its founding, the Science Center’s commercialization and small business programming efforts have supported more than 700 companies, leading to 29,100 jobs with an average salary of $105,000 and $7.6 billion in annual economic impact in Greater Philadelphia. Through its commercialization programs, the Science Center has supported a range of mission-critical innovations that align with DoD priorities, including warfighter readiness, medical technology advancement, and operational resilience.

GTC 360° Advisors is a mission-driven consulting firm specializing in business strategy, government contracts and grants, public affairs, and innovative solutions for complex policy and business challenges. Guided by a vision to simplify complexity and foster public-private partnerships, the firm is committed to building enduring relationships, developing innovative solutions, and pursuing good policy objectives. With a team of seasoned experts and a client-centric approach, GTC 360° Advisors delivers world-class advisory services that help organizations—from startups to Fortune 100 companies—navigate government procurement, drive growth, and achieve lasting impact. The company is recognized for its persistent and passionate approach, treating client causes as their own and building partnerships that unlock value and bring commercial innovation to life.

Credence Management Solutions, LLC is a leading technology-driven management consulting firm serving government and defense clients. With a mission powered by technology, Credence delivers innovative solutions in AI, cloud, cybersecurity, data, enterprise modernization, and blockchain to support critical missions in national security, health, and federal operations. The company is a prime contractor on a wide array of major government contract vehicles, including GSA OASIS, GSA MAS, DLA JETS 2.0, GSA ASTRO, CDAO AI Talent 2.0, Army ITES-3S, Navy SeaPort-NxG, and more, enabling flexible and rapid engagement with federal clients. Credence is recognized for its agility, robust partnerships, and a culture rooted in servant leadership, trust, and continuous professional growth. The company’s vision is to empower clients, employees, and partners to achieve success together, while maintaining a strong commitment to corporate citizenship and community support.

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 University of Louisville Office of Research and Innovation is a premier metropolitan research institution dedicated to advancing knowledge, fostering creativity, and driving innovation across diverse disciplines. Its mission is to support research, scholarship, and creative activity, translating UofL discoveries to benefit Louisville, Kentucky, the nation, and the world. Recognized as a top-tier 'Research 1' university, UofL supports a vibrant ecosystem of research centers, institutes, and collaborative initiatives spanning medicine, engineering, business, and the arts. The office provides robust support for postdoctoral fellows, industry partnerships, entrepreneurship, and access to state-of-the-art core facilities and research tools, making it a hub for innovation, technology transfer, and startup development. UofL is committed to the highest standards of research integrity, compliance, and ethical conduct, ensuring responsible and impactful research outcomes. The office offers comprehensive resources for research participants, including specialized support for children in research, and maintains a strong focus on research policies, technology licensing, industry collaboration, and researcher development through training and funding opportunities. UofL's vision is to support ideas that change, improve, and even save lives, continuously raising the bar for research excellence and societal impact. The office is structured to provide specialized support through dedicated units, research deans, and operational teams, ensuring efficient management and advancement of the university's research enterprise. UofL also maintains transparent and federally compliant practices for indirect cost recovery, ensuring full cost recovery for sponsored projects and providing clear guidance on budget and financials for researchers and partners.

Persist AI is a biotechnology company pioneering the use of AI-driven robotics to accelerate and transform pharmaceutical formulation development. Their mission is to deliver life-saving drugs faster, with fewer side effects, and improved patient outcomes by leveraging advanced automation, machine learning, and high-throughput experimentation. Persist AI's integrated platform addresses the bottlenecks of traditional drug formulation by combining custom robotics, computational chemistry, and proprietary AI models, enabling rapid, scalable, and cost-effective development of complex drug delivery systems such as long-acting injectables. With a global presence and a team of experts in drug delivery, automation, and machine learning, Persist AI is committed to making advanced drug delivery systems more accessible and efficient for the pharmaceutical industry worldwide. The company also demonstrates a strong commitment to data protection, privacy, and security, implementing robust technical and organizational measures in compliance with international standards.

The Metis Foundation is a 501(c)(3) non-profit organization dedicated to advancing military medicine through scientific, educational, financial, and project management support for federally and privately sponsored research, clinical trials, and education. Their mission is to innovate and transform defense health research to save and enhance the lives of service members, their families, and the communities they serve.

EverGlade Consulting connects public sector needs with private sector solutions, specializing in securing and managing non-dilutive federal funding. The company offers a range of services from proposal support to compliance with federal regulations, aiming to enhance the success rate of its clients in obtaining government funding.

QNova LifeSciences is a global regulatory consulting CRO company that is powered by LifeSciences Regulatory Solutions, LLC. QNova LifeSciences encapsulates our company’s mission to: Quality – The foundation of all regulatory and commercialization services. Nova – A guiding light symbolizing innovation and new beginnings. Our name reflects the quality and innovation we bring to every partnership, while staying true to our roots of guiding companies through complex regulatory and commercialization pathways to help life science innovators succeed.

Medmarc, established in 1979 by the healthcare technology industry, is dedicated to providing superior liability insurance protection and risk management solutions to the life sciences and medical technology sectors. The company supports the development, testing, and delivery of medical products that enhance and save lives. Through collaboration with its parent company, ProAssurance, and strategic alliances, Medmarc offers innovative healthcare liability insurance solutions tailored to the evolving needs of life sciences companies.

AeroVironment designs, develops, and deploys uncrewed aerial, ground, and loitering munitions systems, as well as advanced autonomy and mission software for defense, security, and exploration applications. The company has a track record of pioneering innovations in robotics, high-altitude platforms, and planetary flight systems, delivering scalable and adaptable technologies for complex and demanding missions across multiple domains.

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.

Massachusetts Manufacturing Extension Partnership (MassMEP) provides consulting, training, and support for small and medium-sized manufacturers across Massachusetts. The organization advances operational excellence, technology adoption, workforce development, innovation, and supply chain optimization, helping manufacturers improve efficiency and remain competitive in evolving industry landscapes.

ADS, Inc. (Atlantic Diving Supply) is a leading value-added logistics and supply chain solutions provider serving all branches of the U.S. Military, federal, state and local government organizations, law enforcement agencies, first responders, partner nations, and the defense industry. Founded in 1997 in Virginia Beach, VA, ADS has grown into a Top 50 Department of Defense Contractor, recognized for its commitment to legendary customer service, broad procurement options, and innovative product and service offerings. The company is deeply rooted in its community, supporting military families, veterans, and first responders through scholarships, corporate giving, and ongoing service. ADS upholds the highest standards of business ethics, compliance, and quality, as demonstrated by its AS9100D, ISO 9001:2015, and ISO 14001:2015 certifications.

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.

ICON plc is a global provider of clinical, consulting, and commercial services, dedicated to helping pharmaceutical, biotechnology, and medical device companies bring new drugs and devices to market faster. The company offers a comprehensive range of services that span the entire lifecycle of product development, from early clinical phases to post-marketing. ICON is committed to delivering high-quality, harmonized data and innovative solutions to improve patient recruitment, retention, and engagement, while ensuring regulatory compliance and operational efficiency.

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.

Digital Infuzion is a CMMI level 3-appraised information technology firm that specializes in innovative computer services, informatics, and enterprise solutions. With a strong focus on healthcare, the company aims to help clients manage, mine, and make sense of data, driving digital transformations across various sectors. The company prides itself on creativity, openness, and growth, fostering a culture that encourages innovative problem-solving and collaboration.

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.

Founded in 2007, Knowesis is a Woman Owned and Service Disabled Small Business providing health research solutions to the Federal Government. We are experts in Military Health System and Veterans Affairs data to predict health outcomes, evaluate health and medical programs and determine efficacy of interventions.

Reliable Systems Engineering, LLC is a consulting firm specializing in systems engineering for the medical device industry. The company supports clients—particularly startups, contract developers, OEMs, and CMOs—through expertise in system architecture, requirements development, risk management, verification, and cross-functional coordination. Its mission is to bring clarity, structure, and guidance to complex device development, ensuring regulatory compliance and efficient progress through disciplined engineering practices, all rooted in recognized industry standards and decades of experience.

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.

Tria Federal is a premier provider of digital services and technology solutions for the federal government, with a mission to support the health, safety, and operational excellence of veterans, service members, and civilians. Formed through the integration of several legacy companies and the acquisition of Softrams in 2024, Tria delivers end-to-end solutions that modernize, streamline, and transform government systems. The company is recognized for its values-driven culture, commitment to diversity and inclusion, and impactful community engagement. With nearly 1,000 employees across more than 40 states, Tria leverages deep expertise in IT, advisory services, and digital transformation to power possible for its government partners.

TISTA Science and Technology Corporation delivers technology, analytics, and digital transformation for federal agencies, with emphasis on healthcare, supply chain optimization, fraud prevention, and IT modernization. The company integrates artificial intelligence, cybersecurity, cloud, and data engineering expertise to modernize mission-critical systems, enhance operational efficiency, and improve public service outcomes. TISTA is recognized for its application of human-centered design, agile methodologies, measurable impact, and commitment to serving veterans and addressing federal challenges.

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.

Berry Consultants is a statistical consulting company specializing in innovative clinical trial design, analysis, implementation, and software solutions for the pharmaceutical and medical device industry. They focus on adaptive clinical trials and Bayesian analysis, aiming to improve the efficiency and effectiveness of clinical research.

Ancilla Technologies and Services, Inc. is a Service-disabled Veteran-owned Small Business (SDVOSB) founded on Veterans Day in 2015. The company is dedicated to providing superior services by integrating proven business and management practices with teamwork to maximize outcomes for their clients. Ancilla focuses on delivering client-centered services by attracting and retaining team members through competitive salaries, comprehensive benefits, and a rewarding environment. Their mission is to help clients identify and solve their toughest challenges, making a difference and making it better for all those they serve.

Prospect Life Sciences is a medical device development and manufacturing partner offering integrated, end-to-end solutions from concept through global market fulfillment. The company provides comprehensive capabilities in research and design, product development, manufacturing transfer, scalable production, and regulatory compliance, leveraging ISO 13485:2016-certified and FDA-registered quality management systems. With facilities in the USA and Costa Rica, the company serves as a strategic partner for both early-stage and established organizations, enabling efficient, compliant, and scalable innovation in the medical device sector.

Wilson Intelligence Services LLC is a consultancy specializing in communications security, fraud prevention, risk management, and regulatory compliance. Founded in 2010 and headquartered in Richmond, Virginia, the company offers expert services to help organizations address complex security and compliance challenges, with a focus on anti-fraud solutions, enterprise messaging, technical implementation, and regulatory consulting. The team combines 15+ years of domain experience with structured methodologies, robust training resources, and technical tools to deliver hands-on, tailored solutions for clients in IT services, telecommunications, and cloud platform sectors.

ZOLL Medical Corporation, a subsidiary of Asahi Kasei, is a global leader in developing and marketing medical devices and software solutions aimed at advancing emergency care and improving patient outcomes. Founded in 1980 and named after Dr. Paul Zoll, the company is renowned for its innovative technologies in defibrillation, cardiac monitoring, and other critical care solutions. ZOLL is committed to enhancing clinical and operational efficiencies, supporting healthcare professionals and lay rescuers worldwide in addressing serious cardiopulmonary and respiratory conditions.

Brinter is a pioneering US-based MedTech firm focused on revolutionizing tissue engineering through the development of 3D bioprinted biocomposite regenerative implants, known as BioMods™, which aim to restore damaged tissue and replace conventional implants, launching in orthopedics/tendons and ligaments. The company driven by a team of visionary entrepreneurs and leading bioscientists and engineers.

Minnesota Wire is a privately owned, industry-leading custom wire and cable manufacturer based in St. Paul, Minnesota, with over 50 years of experience. The company specializes in designing, developing, and manufacturing high-performance wire, cable, and interconnect assemblies for mission-critical applications across medical, aerospace, defense, and industrial markets. Renowned for its commitment to innovation, quality, and engineering excellence, Minnesota Wire leverages advanced R&D, vertically integrated manufacturing, and a customer-centric approach to deliver life-saving connections and cutting-edge solutions. The company is AS9100, ISO9001, IPC-620, and MIL-STD certified, and is recognized for its contributions to technological advancement, community impact, and sustainability. Minnesota Wire is now a woman-owned business, marking a new era of growth and inclusivity.

Corscience is a German-based medical technology development and manufacturing provider specializing in advanced solutions for defibrillation, patient monitoring, and vital sign acquisition. The company supports OEMs and medtech startups internationally with expertise across R&D, regulatory affairs (including MDR and FDA compliance), quality management, lifecycle management, and technical consulting. Their track record includes the delivery of complex, safety-critical systems and robust integration of electronic, software, and mechanical components in medical devices.

Triple Ring accelerates the pace of innovation allowing our partner companies to drive growth, start new businesses, launch breakthrough products, improve health, and change lives. We are a healthcare-focused Corporate Growth Lab headquartered in Silicon Valley, with offices in Boston, Toronto, and Copenhagen. Our services span three key business lines: Technology translation for US government programs, Corporate Growth Labs, and Technology and product development services. Founded in 2005, Triple Ring has an unparalleled track record supporting clients from startups to many of the world’s largest MedTech and Life Sciences companies.

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.

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.

Inertia is an innovation-driven firm delivering end-to-end design, engineering, prototyping, and manufacturing for medical, clean tech, industrial, safety, and advanced hardware industries. Distinguished by their tightly integrated evidence-based approach—including strategy, human factors, regulatory and advanced manufacturing—they execute at every phase: from early startup product validation through SMB innovation acceleration, to full-scale manufacturing for startup and large enterprises. Their unique differentiator lies in the seamless integration of product strategy, development, and manufacturing under one roof—enabling clients to optimize quality, achieve rapid speed-to-market, and realize measurable cost and risk reductions. With robust quality systems, client-centered project management, and a reputation for transparency, Inertia consistently sets new standards for product innovation and commercialization.

The Geneva Foundation is a 501(c)3 nonprofit established in 1993, dedicated to advancing military medicine through research, development, and education. With a commitment to ensuring optimal health for service members and the communities they serve, Geneva collaborates with various partners to drive innovative medical research and improve healthcare outcomes.

Venable LLP is a global law firm with over 900 professionals, providing comprehensive legal services in regulatory compliance, government affairs, corporate transactions, intellectual property, and complex litigation. The firm is dedicated to empowering clients by focusing on their priorities and goals, ensuring their success in any circumstance. Venable is committed to diversity, inclusion, and community service, fostering an environment where all voices are heard and everyone has the opportunity to thrive.

Metro Preclinical Consulting, LLC, founded in 2024 and based in New Jersey, USA, provides comprehensive support to medtech companies in the strategy and execution of preclinical evidence generation. The company offers a tailored approach to maximize data while minimizing animal use in preclinical development programs, supporting product research and regulatory filings. Metro Preclinical is committed to being a responsive, diligent, and candid partner, guiding products from concept to clinic.