Non-FDA Regulated Medical Devices

Devices not subject to FDA oversight or approval.

Explore MTEC Members with Non-FDA Regulated Medical Devices Capabilities

Visit the MTEC members directory to explore organizations actively contributing to non-fda regulated medical devices research, technology development, clinical trials, and commercialization efforts. Connect with innovators, collaborate on proposals, or initiate partnerships that can accelerate the next generation of non-fda regulated medical devices solutions.

116 Members with Non-FDA Regulated Medical Devices capabilities.

The University of Texas System
The University of Texas System

The University of Texas System is a leading public university system in the United States, dedicated to improving lives through education, health care, and research. With over 256,000 students enrolled across 14 institutions, the UT System is committed to providing affordable access to higher education and producing a skilled workforce to drive Texas's economy.

Georgia Southern University
Georgia Southern University

Georgia Southern University is a vibrant institution with over 26,100 students across three campuses in Statesboro, Savannah, and Hinesville. The university offers 132 degree programs at the associate, bachelor’s, master’s, and doctorate levels, emphasizing student success, community impact, and research excellence. With a commitment to inclusivity and engagement, Georgia Southern fosters a supportive environment for diverse learners, including military-affiliated and adult students. The university is dedicated to transforming lives through education and community engagement, aligning its programs with regional needs. Additionally, Georgia Southern provides accelerated pathways for students to fast-track their master's degrees, enhancing educational opportunities. The university also emphasizes career readiness and public impact research, preparing students for successful careers and contributing to community development.

Teleflex
Teleflex

Teleflex is a global provider of medical technologies designed to improve the health and quality of people's lives. The company focuses on purpose-driven innovation to empower healthcare professionals and enhance patient outcomes across various medical fields.

The University of Texas at San Antonio
The University of Texas at San Antonio

The University of Texas at San Antonio (UTSA) is dedicated to the advancement of knowledge through research, teaching, and community engagement. As a premier public research university, UTSA embraces multicultural traditions and serves as a catalyst for socioeconomic development, providing access to educational excellence and preparing citizen leaders for the global environment.

Auburn University
Auburn University

Auburn University Research & Economic Development is dedicated to advancing research and economic growth through a collaborative effort among its various colleges and departments. The organization focuses on fostering innovation, supporting faculty and student research, and facilitating partnerships with industry and government to address societal challenges and enhance the quality of life. Recent initiatives include the launch of the Team Science Series to promote interdisciplinary collaboration and the development of the Gulf Coast Engineering Research Station to address coastal environmental challenges.

Ethos Solutions LLC
Ethos Solutions LLC

Ethos Solutions specializes in rapid problem solving in dynamic environments through the Ethos IDEALs (Identification, Define, Engagement, Alignment, and Leveraging). Ethos leverages module working groups (or cells) consisting of Subject Matter Expert (SMEs) clinicians, training cadre, warriors, academics, and researchers able to rapidly identify and solve problem sets that require a grounded approach forged in austere and dynamic environments.

University of Arkansas
University of Arkansas

The Institute for Integrative & Innovative Research (I3R) at the University of Arkansas is dedicated to pioneering solutions to complex societal challenges through convergence research. With a mission to advance research excellence and stimulate economic development, I3R focuses on deploying innovations at scale through collaboration across various sectors, including academia, industry, and government.

The University of Texas Medical Branch at Galveston
The University of Texas Medical Branch at Galveston

UTMB is dedicated to supporting research, education, and scholarly endeavors, with a focus on creating the future of healthcare through innovative research and community engagement.

The University of Queensland
The University of Queensland

The University of Queensland (UQ) is one of Australia's leading research and teaching institutions, dedicated to transforming lives through education and research. UQ aims to create a better future by equipping students with the skills and knowledge necessary for their chosen careers, while also addressing some of the world's most complex challenges through innovative research.

The University of Chicago
The University of Chicago

The University of Chicago is a prestigious urban research university committed to rigorous inquiry and intellectual freedom. Founded in 1890, it has produced numerous Nobel laureates and is known for its transformative education and groundbreaking research across various fields. The university fosters an inclusive and diverse learning environment, encouraging participation from all community members.

Boston University
Boston University

Boston University is a major research institution committed to leading breakthroughs across various disciplines. The Office of Research supports and advances research excellence, fostering collaboration among researchers, industry partners, and government leaders to address significant societal challenges.

Baylor University
Baylor University

Baylor University is a preeminent Christian research university committed to addressing the world's most meaningful challenges through top-tier research and scholarship. Recognized as an R1 research institution, Baylor focuses on infusing its distinct Christian mission into its research initiatives, fostering a commitment to excellence and innovation.

University of South Carolina
University of South Carolina

The Molinaroli College of Engineering and Computing at the University of South Carolina fosters innovation by preparing engineers and computing professionals to develop new technologies that will improve lives and the world. The college is committed to addressing real-world challenges through education, research, and community engagement.

Exponent
Exponent

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.

PPD
PPD

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
Simbex

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.

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University of Pittsburgh

Topical Metformin Lotion for Tendinopathy Prevention

University of Pittsburgh study shows topical metformin prevents overuse tendon injury. This work was sponsored through MTEC project 22-02-MPAI-014.

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.

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