This first-of-a-kind web-based resource assists device manufacturers to simplify the process of identifying the correct biological endpoint assessments for intended global regulatory submission pathways. Utilizing the most up-to-date regulatory requirements to determine strategic results, the Biocompatibility Strategy Navigator provides instant recommendations to assist manufacturers to cost-effectively streamline development initiatives.
“We are extremely pleased to offer the industry’s first online solution designed to provide medical device organizations with unprecedented, customized access to the biological tests required for regulatory approval. This novel application is the only resource available in the marketplace with no-cost, open access that delivers strategic recommendations in four simple steps,” commented Jean-Pierre Boutrand, vice president of Global Laboratory Services, NAMSA.
The medical device industry’s definitive resource for laboratory testing for over 50 years, NAMSA offers clients world-class programs that fast-track development efforts and deliver cost-efficient development solutions. To date, NAMSA has helped thousands of clients ensure that their devices enter the international marketplace in the most safe and efficacious manner possible. NAMSA is proud to continue its reputation as the premier industry partner for toxicology, microbiology, chemistry and biocompatibility testing services.
Boutrand concluded, “We are confident that this new application will serve as a valuable resource for global manufacturers as we work together to bring life-saving medical technologies to the market in the most efficient manner possible.”
NAMSA is a medical research organization accelerating medical device product development through integrated laboratory, clinical, and consulting services. Driven by 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 over 1,000 laboratory, clinical, and consulting associates.