Class III
High-risk device and includes devices that may be implanted or support life. Also, devices that are new in technology, and there is no substantially equivalent device currently available.
24 Members with Class III capabilities

Humanetics Corporation is a clinical-stage pharmaceutical company based in Minneapolis, Minnesota, focused on developing and commercializing products to enhance human health and wellbeing. Founded in 1988, the company specializes in radiation modulators, adjunctive oncology therapies, and pulmonary protective therapies, particularly for COVID-19. Humanetics is known for its lead drug candidate, BIO 300, which is being developed as a radioprotectant for military and civilian use, as well as a treatment to improve outcomes in cancer patients receiving radiotherapy. The company is actively engaged in research programs for non-small cell lung cancer, prostate cancer, and head and neck cancers.
Arsenal Medical is dedicated to transforming medical devices with innovative biomaterials. Founded by Carmichael Roberts, Robert Langer, and George Whitesides, the company aims to address unmet medical needs through thoughtfully designed products. Their vision is to provide local therapy for important medical conditions across various therapeutic areas, leveraging expertise in materials science and chemistry.

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.
Exponent is a multidisciplinary science and engineering consulting firm serving sectors including healthcare, energy, manufacturing, and consumer products. The firm offers technical, regulatory, and risk management expertise supporting clients across the product lifecycle, with capabilities in advanced analytical modeling, laboratory and field testing, product safety, failure analysis, and regulatory compliance. Exponent's professionals contribute peer-reviewed research and leadership to major scientific and engineering forums.

Purgo Scientific is a medical device company dedicated to developing effective solutions for the biofilm infections crisis in orthopedic surgery. Their mission is to provide a locally targeted sustained delivery device that ensures the right therapy is delivered to the right place for the right duration, ultimately improving patient outcomes and reducing the impact of surgical site infections.

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

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.

Limax Biosciences is dedicated to revolutionizing tissue healing through innovative biomaterials inspired by the natural slime of slugs. Their hydrogels provide superior adhesion and healing capabilities, addressing unmet medical needs both inside and outside the body.
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.

CorNeat Vision is dedicated to developing innovative biomimetic medical solutions aimed at addressing unmet medical needs across various therapeutic fields. Their mission is to harness biomimicry to improve health and equality worldwide, focusing on creating permanent, synthetic implants that integrate seamlessly with human tissue.

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.

Aerstone is a cybersecurity firm dedicated to elevating businesses beyond the security status quo. With a focus on personalized cybersecurity solutions, Aerstone prioritizes understanding the unique needs and challenges of each client. The company is NSA-certified and boasts over 20 years of experience in the field, offering a boutique approach to cybersecurity that emphasizes quality over quantity. Aerstone's mission is to secure the digital world, one client at a time, by providing tailored strategies that deliver maximum impact. Aerstone's security architecture services are designed to fortify digital landscapes, safeguard assets, and keep organizations ahead of evolving threats, ensuring compliance and business continuity.

Critical Innovations LLC is a medical research and development company focused on creating cutting-edge solutions to health threats across pre-hospital, hospital, and military environments. The company focuses on task-shifting evidence-based interventions to earlier echelons of care and more general specialty levels, to simplify management and allow for rapid provision in emergency and combat environments. The company is dedicated to developing innovative medical devices and technologies that enhance emergency care and trauma management, particularly in military settings.

Citeline offers data, analytics, and digital solutions to support clinical trials, drug development, and regulatory compliance. Their capabilities include AI-powered clinical planning, site selection, patient engagement, real-world data integration, regulatory reporting automation, and in-depth industry analysis for the global life sciences sector.

Theradaptive
Theradaptive’s RESTORE Trial Initiation for OsteoAdapt™ DE
Theradaptive launches RESTORE Phase I/II trial of OsteoAdapt™ DE for faster, precision bone healing in craniofacial injuries. MTEC-funded study targets improved recovery for military and civilian patients.
Altec
Autonomous Rehabilitation Device for Improved Recovery in Warfighters
The OSCIR platform—developed by Altec Inc in collaboration with the Naval Health Research Center—is bringing clinical-grade, real-time movement analysis to the front lines. Funded under MTEC-22-02-MPAI
Medical Technology Enterprise Consortium (MTEC)
The Power of IP: Why It Matters to MTEC and Our Mission
MTEC President highlights intellectual property as essential to protecting innovation, attracting investment, and enabling collaboration. A new partnership with Patenter.io supports members in managing and commercializing IP.
George Mason University
SMART-US Wearable Ultrasound + AI Device for Muscle Force Prediction
AI-powered ultrasound in a wearable—SMART-US delivers lab-grade muscle-force insights anywhere.