Full-Time
MedTech CRO delivering end-to-end device development
$14.81 - $23/hr
Minneapolis, MN, USA
In Person
Bachelor's, Associate's
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NAMSA is a medical device-focused contract research organization (CRO) that provides end-to-end development services. It helps sponsors bring medical devices to market by offering testing, regulatory and quality consulting, reimbursement support, and clinical research. The way it works is through a global team with regulatory expertise and therapeutic knowledge who guide and perform the work needed across the product development lifecycle, from initial testing to regulatory clearance, reimbursement, and commercialization. NAMSA differentiates itself with its worldwide regulatory know-how, depth of therapy-specific expertise, and a commitment to delivering proven, cost-effective solutions that speed up development. The company’s goal is to accelerate medical device product development and successful commercialization by providing comprehensive, reliable services and guidance from concept to market.
Company Size
1,001-5,000
Company Stage
N/A
Total Funding
N/A
Headquarters
Toledo, Ohio
Founded
1967
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Remote Work Options
NAMSA and Lexitas announce strategic partnership to deliver end-to-end ophthalmic medical device development. PR Newswire Today at 4:47am PDT Sponsors gain a single, accountable partner through all stages of product development, with Lexitas' dedicated ophthalmology expertise embedded in NAMSA's end-to-end MedTech development platform TOLEDO, Ohio and DURHAM, N.C., April 30, 2026 /PRNewswire/ - NAMSA, the global leader in MedTech contract research offering end-to-end development services, today announced a strategic partnership with Lexitas Pharma Services, the leading full-service ophthalmology contract research organization (CRO), to deliver comprehensive product development support to ophthalmic medical device sponsors. Through the partnership, Lexitas brings over 15 years of dedicated ophthalmic expertise and proven operational delivery, an extensive investigator site network, and an integrated reading center. By pairing these strengths with NAMSA's robust medical device experience and global CRO capabilities, the collaboration creates a uniquely comprehensive platform for sponsors. Together, NAMSA and Lexitas provide device innovators with a single, accountable partner for the entire development lifecycle, ensuring seamless support and coordination throughout every phase. An Embedded, Integrated Operating Model Unlike traditional referral or subcontracting arrangements, NAMSA and Lexitas will operate as a single, unified team. Lexitas clinical experts - including medical monitoring, ophthalmic imaging specialists, and site strategy leads - are integrated directly into NAMSA's project and study management structure, operating under a shared technology and process platform and a unified quality management system. Sponsors get one team, one set of accountabilities, and one line of sight across their program. What Ophthalmic Device Sponsors Gain * End-to-end product lifecycle support from preclinical and biocompatibility through IDE, pivotal trial, regulatory submission, and commercialization * Specialized ophthalmic clinical execution through Lexitas' network of 700+ investigator sites, integrated reading center, BCVA certification program, and dedicated medical monitoring team * Device-native clinical research expertise, including FDA medical device endpoint fluency, IDE strategy, and device-specific trial design * Deep therapeutic-area coverage across anterior and posterior segment ophthalmic indications, including cell and gene therapy, rare disease and advanced modalities * Global reach across the U.S., Europe, and Asia-Pacific * A single, accountable team under a single contract that reduces vendor management burden and coordination risk for sponsors Executive Perspectives Ophthalmic device sponsors have asked The Bend Bulletin for something the market hasn't been able to deliver in a coordinated way: deep device-specific expertise across the full development lifecycle, paired with specialized ophthalmic clinical execution. This partnership with Lexitas allows The Bend Bulletin to offer exactly that. NAMSA brings the end-to-end development platform ophthalmic device innovators' need; Lexitas brings the unparalleled ophthalmic expertise depth that elevates the clinical stage. Together, The Bend Bulletin is giving sponsors a rare combination: world-class device development under one contract, with the ophthalmic specialization to execute at the highest level. - Brian Smith, Chief Executive Officer, NAMSA NAMSA's global MedTech development platform is a powerful complement to what Lexitas has built in ophthalmology. By embedding its ophthalmic experts across site strategy, imaging, and medical oversight within NAMSA's operating model, the partnership enables sponsors to execute highly specialized ophthalmic trials with greater confidence and consistency. Together, NAMSA's medical device expertise and Lexitas' ophthalmology focus deliver a truly integrated approach that drives value for sponsors and meaningful impact for patients. - Jeanne Hecht, Chief Executive Officer, Lexitas Meet the Joint Team at ARVO 2026 NAMSA and Lexitas will be on-site together at the ARVO Annual Meeting, taking place May 3-6 in Denver, Colorado. Ophthalmic device sponsors and industry partners are invited to visit the Lexitas booth #10032 to connect with the joint team and learn how this strategic partnership can support and advance their development programs. About NAMSA Founded in 1967, NAMSA is a global MedTech Contract Research Organization (CRO) offering end-to-end development services across clinical research, regulatory and reimbursement consulting, biocompatibility testing, and preclinical research. With more than 1,500 experts across the U.S., Europe, and Asia-Pacific, NAMSA serves over 3,000 MedTech companies worldwide, from emerging innovators to established global manufacturers. NAMSA is dedicated to accelerating medical device product development, delivering proven solutions that move products through the development lifecycle efficiently and cost-effectively. Learn more at namsa.com. About Lexitas Pharma Services Lexitas is the leading full-service ophthalmology clinical research organization (CRO). With unmatched expertise and precision in ophthalmic research, The Bend Bulletin deliver tailored approaches, rigorous quality standards, and unwavering commitment to operational success. Its team of experts, including ophthalmologists, optometrists, and clinical operations specialists, brings extensive medical, scientific, regulatory, and operational knowledge across all ophthalmology subspecialties. With a deep understanding of patient treatment pathways, provider and research networks, and market opportunities, Lexitas provides customized solutions that support your needs at every stage of development. Visit lexitas.com for more information. SOURCE NAMSA This is a paid placement. For further inquiries, please contact PR Newswire directly.
TOLEDO, Ohio, March 3, 2025 /PRNewswire/ -- NAMSA, a leading US based MedTech testing, clinical and regulatory consulting firm, announced that it finalized its acquisition of WuXi AppTec's US medical device testing operations on February 28.The acquisition brings together two of the most trusted names in medical device biological safety testing, serving more than 4,000 manufacturers worldwide.Lisa Olson, NAMSA Senior Vice President of Global Laboratory Services notes: "Together, we now have unmatched scientific expertise in biocompatibility, microbiology, preclinical and extractables and leachables testing. With the addition of WuXi AppTec medical device testing facilities in the US, we now have more scientists, more lab capacity and more expertise with a wider variety of medical devices than any other company. This combined expertise will continue to enable our work with clients to develop testing and consulting strategies tailored to their specific device and regulatory pathways."NAMSA has been expanding its reach in recent years as it continues to diversify its offering beyond biological safety testing. Since 2021, the company has acquired no fewer than six companies focused on preclinical or clinical research, making NAMSA one of the leading MedTech focused CROs. Brian Smith, NAMSA's recently appointed CEO noted: "This acquisition is part of our larger strategy to broaden our service offering and solidify our position as the go-to resource for manufacturers bringing new life-saving technologies to market while upholding the same high standards of client focused service you have come to expect from NAMSA."About NAMSAHelping medical device Sponsors improve healthcare since 1967, NAMSA is a leading global MedTech testing, clinical and regulatory consulting firm. With a deep pool of testing, clinical and regulatory experts, and in-depth therapeutic knowledge, NAMSA is dedicated to accelerating medical device product development
TOLEDO, Ohio, Feb. 24, 2025 /PRNewswire/ -- NAMSA, a world-leading MedTech testing, clinical and regulatory consulting firm, announced today that Brian P. Smith has taken on the role of NAMSA's next Chief Executive Officer. Most recently, Brian served as the Chairman and Chief Executive Officer of Ad-Tech Medical Instrument Corp., a leading US neuro-diagnostic company.Andre-Michel Ballester, NAMSA's outgoing CEO, will transition back into his role as a managing partner of ARCHIMED, the healthcare-focused global private equity firm that holds a majority stake in NAMSA.Ballester led the search for a new CEO and notes: "Brian is globally recognized as a respected healthcare executive, having served in various leadership roles over the past 15 years as a Board Member, Operating Partner, Chairman of the Board, and Chief Executive Officer with extensive experience in operational, commercial, and innovation strategies. Brian's international experience, having lived and worked in Hong Kong, Shanghai, and Singapore, will be invaluable as we continue to expand our global footprint."Smith adds: "I am thrilled to join an organization with the history, reputation, and contribution to improved patient outcomes that NAMSA has repeatedly demonstrated for decades. I look forward to making my own contribution to this ongoing success story."NAMSA recently announced that it had signed a definitive agreement to purchase the US medical device testing operations of WuXi AppTec
Under the agreement, NAMSA will acquire WuXi AppTec facilities in Minnesota and Georgia.
Japanese med tech leader Terumo announces strategic outsourcing partnership with Namsa.