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1 PEOPLE > SCIENCE > SOLUTIONS Our difference Our foundation Our focus ANALYTICAL CHEMISTRY & MATERIALS CHARACTERIZATION EFFICACY (Functional testing) BIOCOMPATIBILITY (in vivo & in vitro toxicology) CLINICAL TRIALS STERILITY ASSURANCE & MICROBIOLOGY TESTING CONSULTING AND ADVISORY SERVICES STERILIZATION MONITORING PRODUCTS
2 PEOPLE Our difference Founded in 1967 in Perrysburg, Ohio, by Dr. Ted Gorski and his wife Lucille, NAMSA remains family owned and operated. Dr. Gorski recognized the need by medical device manufacturers for quality control testing of biomedical products and opened a new lab in Northwood, Ohio in It was his vision that NAMSA would play a vital role in helping companies bring safe products to market.
3 PEOPLE Our difference NAMSA has been serving clients for more than 35 years. Our company employs over 300 associates across the globe offering both testing services and sterilization monitoring products. We are headquartered in Northwood, Ohio with facilities throughout the world.
4 PEOPLE Our difference NAMSA VISION Our vision is to be the premier global resource providing non-clinical, clinical, and advisory services to medical device, pharmaceutical, and biotechnology companies. We collaborate with our customers to bring safe, effective, and compliant products to market. We are passionate about the work we do because the technology and therapies that pass through our hands touch millions of lives.
5 : OUR FACILITIES PEOPLE Our difference NORTHWOOD, OH IRVINE, CA ATLANTA, GA LYON, FRANCE Our International locations include: LABORATORY: Biomatech (Lyon, France) OFFICES: Germany, Israel (MedNet), United Kingdom (MET), Japan (Senkom), Singapore (BRASS)
6 PEOPLE Our difference NAMSA people have extensive experience working with companies of all sizes and a wide range of medical disciplines. Cardiovascular Dental Drug Delivery Gastrologic Neurologic Obstetrics/Gynecology Ophthalmology Orthopedic Tissue Engineering Urologic Wound Healing Our clients include entrepreneurial and start-up enterprises along with global Fortune 100 companies.
7 PEOPLE Our difference NAMSA CERTIFICATIONS & ACCREDITATIONS All NAMSA and Biomatech laboratories are fully certified and accredited according to the highest industry standards. Testing is performed in accordance with the requirements defined in 21CFR part 58, 820 (US FDA, GLP, and QS regulations). Biomatech is accredited to international quality systems standard ISO and NAMSA U.S. laboratories are certified to ISO 13485:2003 and are compliant with ISO
8 SCIENCE Our foundation ANALYTICAL CHEMISTRY & MATERIALS CHARACTERIZATION EFFICACY BIOCOMPATIBILITY CLINICAL TRIALS STERILITY ASSURANCE & MICROBIOLOGY ANALYTICAL CHEMISTRY & MATERIALS CHARACTERIZATION NAMSA s chemistry laboratories provide analytical support for the development and quality audit of medical devices, reagents, and excipients. We offer a comprehensive range of chemistry testing services to help ensure product safety, quality and consistency during all stages of development.
9 SCIENCE Our foundation ANALYTICAL CHEMISTRY & MATERIALS CHARACTERIZATION EFFICACY BIOCOMPATIBILITY CLINICAL TRIALS STERILITY ASSURANCE & MICROBIOLOGY EFFICACY (Functional Testing) We help medical device manufacturers verify that their products perform according to their intended function. Our scientists offer a broad range of in vivo models and analysis tools to provide data in support of a specific application of a device.
10 SCIENCE Our foundation ANALYTICAL CHEMISTRY & MATERIALS CHARACTERIZATION EFFICACY BIOCOMPATIBILITY BIOCOMPATIBILITY Safety evaluation studies in vitro and in vivo are conducted on a variety of biomaterials, medical devices and related products to identify the presence of toxins or any potentially harmful effects of the product. CLINICAL TRIALS STERILITY ASSURANCE & MICROBIOLOGY In addition to the full range of ISO safety testing, NAMSA will customize test programs and protocols to accommodate the characteristics of unique devices and materials.
11 SCIENCE Our foundation ANALYTICAL CHEMISTRY & MATERIALS CHARACTERIZATION EFFICACY BIOCOMPATIBILITY CLINICAL TRIALS STERILITY ASSURANCE & MICROBIOLOGY CLINICAL TRIALS Clinical trials in compliance with EN540 regulations and ISO standards are performed to assess device performance, possible secondary effects and risk acceptability. These studies are required for implantables, Class III and some Class 2b devices. Studies may be conducted according to Good Clinical Practices (GCP) and International Conference of Harmonization (ICH).
12 SCIENCE Our foundation CHEMISTRY & MATERIALS CHARACTERIZATION EFFICACY BIOCOMPATIBILITY CLINICAL TRIALS STERILITY ASSURANCE & MICROBIOLOGY NAMSA offers a complete sterility assurance program - sterilization and packaging validation, environmental monitoring and shelf life studies. Our facilities contain laboratories for bacteriology and sterility testing, clean rooms, aging chambers, and media preparation. STERILITY ASSURANCE & MICROBIOLOGY Beyond sterility assurance programs we perform: Antimicrobial Testing Bacterial Endotoxin (LAL) Microbial Limits Reusable Device Studies Biological Indicator Performance Studies
13 SOLUTIONS Our focus TESTING TESTING Our goal is to use our expertise and reputation at each juncture in the product development process. We work to help move from concept to production quickly. CONSULTING PRODUCTS
14 SOLUTIONS Our focus TESTING CONSULTING NAMSA Advisory Services With over 35 years in the medical device industry, we offer more than just testing. We partner with you to create customized solutions. CONSULTING PRODUCTS Services we offer beyond testing: Regulatory Interface & Meeting Preparation Quality Assurance Auditing Risk Assessment On-Site Seminars & Training Packaging Services On-site Consultation Bone/Tissue Interface & Investigational Pathology Histopathology Services Contact : Hugues DANJOU hdanjou@namsa.com Tel :
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