According to the U.S. Food and Drug Administration (FDA), a medical device is “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
- recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them
- intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
- intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.”
All medical devices have a unique and thorough set of testing requirements enforced by the FDA, China Food and Drug Administration (CFDA), EU Notified Bodies, and other regulatory bodies that need to be fulfilled before entering the marketplace.
NAMSA is a respected medical device contract research organization (CRO), and the world’s only medical research organization (MRO) with 50 years of experience with medical device, IVD, regenerative medicine and combination product testing. We follow the standards set by the device industry; in fact, we help set them. In other words, we not only do medical device testing, we are the definitive industry source in medical device testing. NAMSA accelerates our client’s medical devices through integrated regulatory, toxicology, microbiology, chemistry, clinical and quality services to ensure the device will get to market in a safe, effective and timely manner. Our ability to apply unique combinations of specialties to assist our clients has helped guide us to become more than just a CRO.
We are a medical research organization; whether you are performing Materials Characterization or Preclinical Biocompatibility Testing, NAMSA has well-equipped testing facilities, vivariums, surgical teams and Technical Specialists located worldwide with the expertise to get your product through a comprehensive testing program. For more information regarding our facility locations, please visit our NAMSA’s locations page.
Materials Characterization and Analytical Chemistry
Materials Characterization and Analytical Chemistry testing defines the components that make up a medical device, confirming its identity and enabling assessment of reproducibility in manufacturing and processing. Using our deep knowledge of science and regulation, we offer an extensive range of these testing services to help secure product safety, quality and consistency during all stages of development.
Some of our capabilities include, but are not limited to:
- Physiochemical Testing
- Fourier Transform Infrared Spectroscopy (FTIR)
- Thermal Analysis
- High Performance Liquid Chromatography
- Extractables and Leachables
- Spectroscopic Assays (UV/VIS,IR)
Preclinical Studies are executed to test and verify the intended performance of a medical device, IVD or regenerative medicine product. Our experts use a broad range of in vivo models and analysis tools, and comply with methods and regulations described by the European Committee for Standardization (CEN), US Food and Drug Administration (FDA) and other applicable guidelines to provide our clients with accurate results.
These studies include:
- Cadaveric Non-Clinical Testing
- Drug Delivery
- Specialized Pathology Services
- Neurosurgery and Spine Surgery
- Orthopedic and Bone Healing
- Physician Training
- Tissue Engineering
- Urogenital System
- Wound Healing
- Safety Studies
- Reconstructive and General Surgery
Our preclinical testing facilities and vivariums are specially designed for the conduct of in vitro and in vivo safety evaluation studies on a variety of biomaterials, medical devices, and combination products. These types of tests are performed to identify the presence of toxins or any other potentially harmful effects. Biocompatibility testing ranges from the initial screening of new materials to product release testing, periodic audit testing, and non-clinical or pre-market safety evaluations to meet current FDA and international standards.
Some of these Biocompatibility tests include, but are not limited to:
Sterility Assurance and Microbiology Testing
Microbiology testing identifies microorganisms and their impacts on other living organisms and sterility testing assures the absence of viable contaminating microorganisms. NAMSA’s facilities contain laboratories for microbiology and sterility testing as well as aging chambers.
Sterility Assurance and Microbiology tests we conduct include, but are not limited to:
- Sterilization Validation
- Environmental Monitoring
- Packaging Validation and Shelf Life Testing
- Reusable Device Studies
- Antimicrobial Testing
- Disinfection Studies