TOLEDO, OHIO – (BUSINESS WIRE) – NAMSA®, the world’s only Medical Research Organization (MRO) that accelerates medical device development through integrated laboratory testing, clinical research and regulatory consulting services, announced today the launch of its in vitro diagnostic (IVD) development business to provide global manufacturers a proven resource for expedited commercialization outcomes delivered via NAMSA’s “Uniquely IVD” regulatory, quality and clinical research services.
“The IVD industry is expanding more quickly than ever, outpacing medical device industry growth in several geographies, and is expected to reach $69B globally by 2024 (GlobalData). Due to the increased demand by patients and healthcare providers for more rapid diagnoses and treatment plans, the need for novel and highly-accessible IVD products will only intensify. Sponsors, who have limited options for IVD-focused Contract Research Organizations (CRO), will now benefit from this new service offering and the knowledge gained through our presence in every major IVD marketplace in the world,” commented Katie Schaaf, General Manager of NAMSA’s IVD business.
The IVD industry has experienced an increase in regulatory scrutiny with the publication of the European Union’s In Vitro Diagnostic Regulation (IVDR), taking effect May 2022, in addition to a growing need for clinical evidence to support international regulatory approvals. NAMSA, frequently collaborating with global regulatory bodies to understand expectations and new regulations, recognizes how to navigate the international regulatory landscape and is recognized by authorities as delivering trusted, highly-reliable IVD development outputs related to regulatory, quality system and clinical research initiatives.
“We are uniquely positioned to empower IVD manufacturers with accelerated, cost-effective development outcomes. Unlike other CROs, our team of IVD experts are solely focused on providing proven solutions for the unique challenges and needs of in vitro diagnostic technologies. This not only allows manufacturers to achieve clinical endpoints more quickly, but also helps them make more informed decisions that fast-track global delivery of life-changing IVD technologies,” concluded Ms. Schaaf.
For a complete listing of NAMSA’s IVD solutions and service offerings, please visit: https://www.namsa.com/ivd-cro-overview/.
Meet with NAMSA
Global manufacturers interested in NAMSA’s proven IVD services are invited to meet with our experts at the upcoming American Association for Clinical Chemistry (AACC) Annual Scientific Meeting in Chicago, Ill. from July 31 – August 2. Click here for more information, or to sign up for a complimentary consultation.
Additionally, NAMSA will be in attendance at the following conferences and trade shows. Please check our events webpage for regular updates:
- Next Generation Diagnostics Summit (August 20-24; Washington, D.C.)
- China International Medical Device Regulatory Forum (September 13-16; Fuzhou, China)
- MEDLAB Europe (October 2-4, 2018; Barcelona, Spain)
NAMSA is a Medical Research Organization (MRO), accelerating medical device product development through integrated laboratory, clinical and consulting services. Driven by our regulatory expertise, NAMSA’s MRO® Approach plays an important role in translational research, applying a unique combination of disciplines – consulting, regulatory, preclinical, toxicology, microbiology, chemistry, clinical and quality – to move clients’ products through the development process, and continue to provide support through commercialization to post-market requirements, anywhere in the world.
NAMSA operates 13 offices throughout North America, Europe, the Middle East and Asia, and employs 1,000 highly-experienced laboratory, clinical research and regulatory consulting Associates.