— CLIENT TESTIMONIALS — DELIVERING SUPERIOR CLIENT RESULTS ACHIEVING SUCCESS FOR OUR CLIENTS NAMSA’s full continuum CRO development services and solutions are designed around one goal: achieving client success. From product development strategy—medical device testing—regulatory, reimbursement and quality consulting—and clinical research services, we are committed to helping clients overcome development hurdles, mitigate concerns and streamline development efforts. We are the CRO industry’s premier partner for accelerated, cost-efficient and efficacious development outcomes that lead to commercialization success. ICHOR Vascular, Inc., a start-up firm focused on the treatment of Peripheral Arterial Disease (PAD) and Limb Ischemias, partnered with NAMSA for the development of the ICHOR Panacea Vascular Embolectomy Catheter System. Operating as a virtual start-up, ICHOR was tasked with the challenge of bringing a 510(k) device to the U.S. marketplace with limited development and regulatory knowledge, restricted resources and a desire to make a timely exit following clearance. ICHOR, by applying NAMSA’s MRO Program throughout the development continuum, achieved a 30 percent savings in timelines while also shaving off $26M in costs throughout the development lifecycle. Biom’Up®, a European-based medical device firm focused on collagen-based absorbable medical products for biosurgery, recently sought to obtain its first Class III Investigational Device Exemption (IDE) and Premarket Approval (PMA) in the United States. Biom’Up, with the utilization of NAMSA’s MRO® Approach methodology, achieved record-breaking results of $17M in cost savings and 23 months in accelerated timelines. Through NAMSA’s Medical Research Organization (MRO®) Approach, clients around the world are realizing multiple time and cost efficiencies throughout all phases of medical device development. Heraeus, a German-based services firm focused on providing innovative solutions to medical technology companies, recently partnered with NAMSA to conduct a pre-clinical development program. Utilizing NAMSA’s anatomic/bioskills services, multiple successes were achieved throughout, including significant acceleration of product development timelines and cost savings. CVRx®, a Minneapolis-based cardiovascular medical device company, is dedicated to the development of proprietary active implantable technology for the treatment of high blood pressure and heart failure. CVRx’s one-of-a-kind product, the Barostim neo™, is currently CE marked in Europe. The organization, requiring quick market access for a successive U.S. heart failure pivotal trial, quickly turned to NAMSA to help accelerate the process. Relying on NAMSA’s clinical and consulting services throughout, CVRx realized both cost efficiencies and time savings as a result of the partnership. SUBSCRIBE TO NAMSA EVENTS NEWSLETTER SIGN UP JOIN THE NAMSA NETWORK Update your profile, post comments on the blog; sign-up for events, webinars and classes; receive email alerts and more. REGISTER Already have an account? Please Login Here NAMSA CLIENT PORTAL Login to the NAMSA Client Portal for sample submissions, testing reports, project tracking, and more. CLIENT PORTAL Careers Accreditations & Certifications Site Map Terms of Use Privacy Statement EU-U.S. & Swiss-U.S Privacy Shield Website Accessibility Statement International Sites: United Kingdom France Germany China Japan CONTACT US +1 866 · 666 · 9455 (toll free) +1 419 · 666 · 9455 (outside of USA) © North American Science Associates, LLC 2021 Website Design, Hosting and Maintenance by MVP Marketing + Design Cookie SettingsAccept all cookies