namsa.comContract Research Organization for Medical Devices and IVDs | NAMSA

Services Medical Device Consulting Medical Device Consulting Overview FDA U.S. Agent Services Clinical Trial CRO Consulting International Medical Device Registration Consulting Mock Audits Medical Device Reimbursement Consulting Medical Device Clinical Research Staffing Medical Device Validation & Safety Consulting ISO Compliance & Quality Systems Consulting Medical Device Regulatory Consulting Medical Device Strategy Consulting Testing Biocompatibility Strategy Navigator NAMSA Test Navigator Testing Overview Medical Device Testing Services Biocompatibility Testing Services Biological Safety Services Cleaning Study Development & Execution Environmental Monitoring Services Histopathology Services Material Characterization & Analytical Chemistry Method Development & Validation Services Packaging Validation Services Particulate Analysis Services Physician Training Preclinical Studies Medical Device Risk Assessment Validation for Reprocessed Medical Devices Long-Term or Accelerated Shelf Life Testing Sterilization Validation Services Other Microbiology Testing Services Clinical Clinical Overview Biostatistics Consulting & Services Clinical Auditing Services Clinical Evidence & Post-Market Studies CTMS Services & Medical Data Management Data Safety Reporting & Clinical Events Field Clinical Engineer Staffing Medical Writing Services Clinical Research Management Clinical Study Design IVD EXPERTISE IVD CRO OVERVIEW IVD SERVICES IVD EXPERTISE Therapeutic Expertise Therapeutic Expertise Overview Anesthesia & Respiratory CRO Dental CRO Diagnostic Imaging & Radiology CRO Diabetic Care CRO Gastroenterology & Bariatrics CRO IVD & Companion Diagnostics CRO OB/GYN – Obstetrics and Gynecology Orthopedics CRO Regenerative Medicine CRO Dermal Wound Care & Dermatology CRO Cardiology CRO Ear, Nose & Throat CRO General Plastic Surgery CRO Neurosurgery & Spinal Surgery CRO Hematology & Oncology CRO Ophthalmology CRO Peripheral Vascular CRO MRO Medical Research Organization Stage 1 – Concept / Feasibility Stage 2 – Design Validation / Preclinical Testing Stage 3 – Clinical Stage 4 – Market Approval Stage 5 – Post-Market Resources Resource Library: Information for Medical Device Developers Events Medical Device Development & Regulatory Webinars Medical Device Topics Training Series Podcasts Medical Device Development E-Learning Biocompatibility Strategy Navigator NAMSA Test Navigator EU MDR & IVDR Planning Resources Useful Links for Medical Device Manufacturers Company About Us Client Testimonials Our Accreditations & Certifications Our History: From CRO to MRO Our Values: Integrity, Sustainability, Efficiency Careers Careers Overview Open Positions Total Rewards Our Global CRO Locations Contact Us Blog NAMSA Blog: News, Trends & Education Asian Market Clinical & Consulting European Market FDA Industry Reposts Microbiology MRO Packaging & Stability Preclinical Regulatory Toxicology Login Search Will you be prepared? Let NAMSA help guide you to compliance. Learn More MDR EU Compliance Countdown: 0 0 Day 0 Hour IVDR EU Compliance Countdown: 0 0 Day 0 Hour NAMSA is the only Medical Research Organization… …that reduces time to market & costs for medical device product development. We do this by providing global expertise in Consulting, Laboratory Testing Services & Clinical Research. It’s called the MRO ® Approach. Concept / Feasibility Your innovation starts here – Charting your strategy from bench to bedside is underway. Do you know how to minimize product development risk at this stage? Learn More Design Validation & Preclinical Your innovation becomes a product that needs to be evaluated, refined, and finalized. Have you created a testing strategy to save you time and money? Learn More Clinical The successful evaluation of your product through human clinical trials in a timely manner requires experience. Do you know how to streamline this stage in your development? Learn More Market Approval Device approval by the appropriate regulatory governing body is critical. Does your submission meet all requirements for clearance and is your team commercially ready? Learn More Post-Market Post-market surveillance to monitor the safety of your device is imperative. Does your post-market strategy include physician training, lot release testing, or quality audits? Learn More NAMSA’s medical device experts work across a multitude of therapeutic areas including Cardiovascular, Orthopaedic, IVD, and Wound Care. The combined experiences of our specialists, enables us to customize your quality system, design validation, testing, and clinical trials to your specific therapeutic needs. NAMSA MRO® Approach NAMSA is a Medical Research Organization (MRO), accelerating 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, preclinical, toxicology, microbiology, chemistry, clinical and quality—to move client’s products through the development process, and continue to provide support through commercialization to post-market requirements, anywhere in the world. (LEARN MORE) Contact Us +1-866-666-9455 (toll free) +1-419-666-9455 (outside of USA) +1-419-662-4386 (fax) Email & Social Media namsa.com/contact-us | LinkedIn | Twitter Therapeutic Expertise Therapies that affect physical or biological processes of the body are known as “medical” therapies. These therapies can include medications, alterations in diets, changes in sleep habits, increased physical activity, stress reduction and more. NAMSA has extensive medical device testing and clinical trial experience across all of the therapies listed below. Click to find out more or contact us directly. BLOG Diagnostic Developers Look to EUA Submission to Combat Novel Coronavirus (COVID-19) Lillian Li February 12, 2020 Background China initiated its highest level of emergency response to the COVID-19 outbreak (also referred to as the novel Coronavirus) on 20 January 2020. The National Medical Products Administration (NMPA), ... Read All EVENTS NAMSA IVD Summit April 22, 2020 NAMSA is proud to present this half-day seminar and networking event that will focus on addressing key issues in the IVD product development cycle to help manufacturers thrive in an evidence-based environment. The topics discussed will help identify industry best practices in regulatory and clinical research requirements. Read All CAREERS Exceptional Careers – Inspiring Experiences Working at NAMSA will allow you to apply your expertise and knowledge to make a difference in the lives of others. Curious about our opportunities? View All Contact Us +1-866-666-9455 (toll free) +1-419-666-9455 (outside of USA) +1-419-662-4386 (fax) Library Get the latest white papers, brochures, datasheets and so much more to help you get ahead in the development of your medical device. Education Learn from industry leading professionals how to get your product approval easier and with less regulatory resistance. NAMSA has been educating medical device professionals on product development for over 40 years. Services Medical Device Consulting Testing Clinical Research Services MRO Medical Research Organization Medical Device Testing Services Our Therapeutic Expertise Stage 1 Medical Device Development Services: Concepting & Feasibility Stage 2 Medical Device Development Services: Design Validation/Preclinical Testing Stage 3 Medical Device Development Services: Clinical Stage 4 Medical Device Development Services: Market Approval Stage 5 Medical Device Development Services: Post-Market Resources Resource Library: Information for Medical Device Developers Education Events Useful Links for Medical Device Manufacturers Blog NAMSA Blog: News, Trends & Education Login Subscriber Login Company About Us C...