Good Manufacturing Practices

SIMETRI is a woman-and-minority owned small business based in Winter Park, Florida, specializing in modeling, simulation, and training technologies. Founded in 2009, the company focuses on delivering innovative products and services that enhance the human experience and improve client outcomes through advanced training and program management analysis.

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.

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.

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.

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.

Prolucid Technologies Inc. specializes in custom software development for highly regulated industries, including medical and nuclear sectors. With over 17 years of experience and more than 1200 projects completed, Prolucid delivers robust, secure, and compliant software solutions. The company is ISO 13485 certified for medical software and adheres to CSA N299.1 and ISO 9001 standards for nuclear applications. Prolucid offers end-to-end services from project definition and planning to design, development, verification, and ongoing support, leveraging advanced technologies such as AI, ML, computer vision, and cloud infrastructure.

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.

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.

CellBios is a biotechnology company specializing in the design, development, and manufacturing of single-use bioprocessing and medical device solutions for healthcare, biotechnology, and regenerative medicine sectors. The company operates GMP and ISO-certified cleanroom facilities, offering a comprehensive portfolio of cryopreservation products, bioreactors, fluid management systems, advanced packaging, and specialty devices. By leveraging expertise in extrusion, molding, assembly, sterilization, quality control, and regulatory compliance, CellBios provides customized, scalable solutions to support blood transfusion, cell and gene therapy, biologics manufacturing, and clinical workflows.

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.

SASRAC provides trusted, authoritative research and consulting services focused on occupational and environmental safety and health challenges. With expertise in developing hearing damage risk criteria, measuring impulsive noises, evaluating hearing protector performance, and creating wireless audiometric testing technologies, SASRAC has been at the forefront of applied research since the 1970s. Founded by experienced professionals from the USAF and CDC/NIOSH, SASRAC is dedicated to advancing technologies in audiology, bioacoustics, and hearing conservation.

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.

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.

Cepheid is a global leader in molecular diagnostics, dedicated to improving healthcare by developing, manufacturing, and marketing automated, easy-to-use molecular systems and tests. Their mission is to provide rapid, accurate, and actionable genetic testing for a wide range of infectious diseases, oncology, and human genetics. Cepheid's flagship GeneXpert System delivers scalable, sample-to-answer PCR testing for institutions of any size, supporting both centralized and decentralized care. The company is committed to expanding access to high-quality diagnostics worldwide, supporting public health initiatives, driving innovation in molecular testing, and advancing sustainability and responsible business practices.

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.

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.

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.

TDA Research, Inc. is dedicated to addressing complex real-world problems through innovative research and development in chemical processes, materials, and hardware. With a focus on agility and collaboration, TDA partners with clients in defense, aerospace, energy, and chemical industries to deliver cutting-edge solutions and technologies.

Gel4Med is a commercial-stage company pioneering the use of smart, bioinspired materials to address major challenges in medicine. Founded out of Harvard Innovation Labs, Gel4Med leverages its proprietary Smart Materials Platform™ (SMP™) to develop advanced therapeutics and devices, with a mission to enhance health outcomes and access for all patients. The company is committed to creating novel biomaterials that improve regenerative medicine and surgical solutions, and has achieved significant milestones including FDA clearance for its lead wound care product, G4Derm™ Plus.

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.

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.

Emergent BioSolutions is dedicated to developing, manufacturing, and delivering medical countermeasures that address public health threats. With a mission to protect and enhance life, the company focuses on innovative vaccines and therapeutics to combat critical health challenges, including the ongoing opioid crisis.

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.

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.

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.

Cook MyoSite, a subsidiary of Cook Group, has been advancing human muscle cell technology since 2002. Operating under ISO 9001:2015-certified quality standards, we specialize in primary human skeletal muscle-derived cells and fibro-adipogenic progenitors sourced from healthy donors and individuals with neuromuscular, metabolic, and rare disorders. Our offerings include custom cell procurement, specialized media formulations, and contract manufacturing services—supporting both academic research and clinical development in regenerative medicine. Beyond research tools, Cook MyoSite is pioneering autologous muscle-derived cell therapies. Our investigational product, iltamiocel, is currently in a Phase III clinical trial for fecal incontinence, demonstrating our commitment to translating cell-based science into real-world solutions. With expertise in GMP manufacturing, analytical testing, and tailored partnerships, we empower collaborators to accelerate innovation in musculoskeletal and neuromuscular health worldwide.

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.

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.

Tunnell Government Services, Inc. is a subsidiary of Tunnell Consulting, Inc., dedicated to providing professional services to government agencies. The company focuses on transforming organizations to achieve sustainable results and fulfill agency missions. With expertise in public health preparedness, biodefense lab support, and scientific project portfolio management, Tunnell Government Services partners with government organizations to address the greatest threats to public health and enhance organizational performance.

Life Protect specializes in the design and manufacture of novel personal protective equipment (PPE), such as face masks and N95 and N99 respirators in the United States with a focus on scientific development, clinical integration, supply chain reliability, and regulatory compliance for healthcare and emergency use.

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.

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.

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.

Athena GTX is dedicated to advancing wireless, mobile, patient-worn monitoring solutions for both military and civilian markets. The company focuses on connecting patients and providers through state-of-the-art medical and communication technology, developed and produced in Iowa. Athena GTX aims to enhance patient outcomes by integrating innovative wireless technology with reliable devices, supporting first responders and medical professionals in various challenging environments.

International Fabric Machines appears to be in the process of establishing its online presence, as the domain is not yet connected to a website. The company may be involved in the fabric machinery industry, but specific details about its mission and vision are not available at this time.

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.

Tensentric is a contract design and manufacturing firm focused solely on medical device, in vitro diagnostic, and advanced therapy markets. We're ISO13485 certified and FDA registered to help our clients bring their new technology and products to market.