NAMSA™ can assist you with

Research & Development Product Process

Chemical characterization of materials – Materials characterization testing establishes a baseline fingerprint of a material so the results of biological testing can be firmly linked to a specific formulation.

Function and performance studies – NAMSA™ customise specific methods and models to evaluate the in vivo efficacy of your unique device, using preclinical studies to select prototypes and provide understanding of device performance. NAMSA™ study models are selected by veterinary surgeons to assess function and performance. NAMSA™ in vivo studies mirror the clinical end-use of the device, to verify that it will perform with an appropriate host response in a specific application. NAMSA™ create the most effective program by using the same analysis tools for preclinical and clinical studies and follow methods described in the European Committee for Standardization (CEN), U.S. Food and Drug Administration (FDA) standards, and other applicable guidelines.

Advanced histological technology – Valuable tissues can be collected and processed on-site under the supervision of a board certified pathologist. Histopathology services are also provided on fixed tissues from outside sources.

Biological safety evaluation plans – A wide range of medical devices are introduced almost daily in today’s market, and established standards are constantly being redefined. Any novel device needs to undergo risk assessment for biological hazards and risk characterization. At NAMSA™, biological safety evaluation plans are created to protect your medical device development process and keep it moving forward.

Product and process risk assessments – NAMSA™’s specific safety programs follow FDA guidance and ISO 10993 standards. The NAMSA™ team — includes biostatisticians, clinicians and experts—giving you a product development process that is driven by the best combination of the very best people and processes available anywhere in the world.

Shelf-life and accelerated aging studies – Accelerated aging studies are designed to increase the rate of chemical degradation or physical change of a substance or product by using exaggerated storage conditions as part of the formal stability study. Data from these studies, in addition to long-term stability studies, can be used to assess longer-term chemical effects of non-accelerated conditions and to evaluate the effect of short-term excursions outside the label storage conditions.

Cleaning studies – Regardless of the methods chosen, an effective residual analysis program is essential for maintaining an acceptable level of cleanliness for medical devices.

Particulate analysis – Medical device particulates testing is performed on injections, parenteral infusions, and medical devices. Since there is no one test method for testing parenteral products or medical devices, NAMSA™ prepares a test specification for every sample tested, which may be set up in advance of the sample’s arrival. When performing particulate analysis, NAMSA™ consider how manufacturing, sterilization, shipping and distribution, packaging, shelf storage, and use with other devices affect the particulate levels of the medical device.

Human Anatomic Services – NAMSA™’s research facility in Brooklyn Park, Minnesota offers a state of the art surgical facilities allowing medical device companies to showcase their devices, while supporting their participants. With top of the line video equipment, sizable classroom space for dry labs, internal and external data links, video presentation capabilities, and wet lab and surgical suites, this facility functions as the ideal cadaver lab for physician training and medical device training.

Physician Training – NAMSA™ offers an accessible and adaptable research and training cadaveric or animal laboratory designed to facilitate a wide range of scientific needs. NAMSA™’s state of the art facilities coupled with years of experience from our clients offers an ideal environment for this critical step in the development process.

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 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. NAMSA™ performs testing to evaluate biocompatibility appropriate to the intended use of the component material or finished product. These biocompatibility tests challenge various biological models with the test material or a suitable extract. Specific safety programs follow FDA guidance and ISO 10993 standards. Primary test categories used to determine biological effect include:

  • Cytotoxicity
  • Sensitization
  • Intracutaneous irritation
  • Acute systemic toxicity
  • Subchronic toxicity
  • Genotoxicity
  • Implantation
  • Hemocompatibility
  • Chronic toxicity
  • Carcinogenicity
  • Reproductive/developmental
  • Biodegradation

To view our biocompatibility test matrix, click here.

Histopathology – In addition to the wide range of in vitro and in vivo toxicology services, NAMSA™ offers histopathological services. Tissues can be collected and processed on-site under the supervision of a board certified pathologist. Services are also provided on fixed tissues from outside sources.

  • State-of-the-art histology laboratory
  • Specialised tissue-implant processing using the Exakt® Histological System
  • Routine paraffin processing and sectioning
  • Soft and hard resin (plastic) processing and sectioning
  • Non-decalcified and decalcified processing and sectioning
  • Custom sample preparation and sectioning
  • Histochemistry capabilities
  • Photomicrograph documentation
  • Timely and efficient reporting

Please visit NAMSA™ website for details.
NAMSA™ Website