Understanding Your Needs Through Experience
For over 40 years, NAMSA has been supporting the medical device and pharmaceutical industries through a wide variety of testing services, all designed to ensure safety, efficacy and regulatory compliance. As a privately owned and managed company, we are completely focused on our clients needs and the quality of our testing and consulting services. Our technical staff members understand the complex compliance requirements of the FDA, European Notified Bodies, the Japanese Ministry of Health and Welfare and other regulatory agencies worldwide. We work with our clients to develop individualized testing programs, guiding them through the simplest test or the most complex development project. We also provide guidance through the submission and regulatory approval process. Our technical specialists provide accurate reports and supporting data that is easy to understand and presented in ways that are preferred by regulatory bodies. And we provide services to interpret test results and identify and discuss problems that may occur at any point during the product development process.

Clinical trials in compliance with EN540 regulations and ISO 14155 standards are performed at NAMSA's laboratory in France, Biomatech.

In addition to advisory and testing services, NAMSA offers a wide range of sterilization monitoring products used by medical device and pharmaceutical manufacturers, contract sterilizers. View our online product catalog.

• Biological indicators for steam, ethylene oxide, dry heat, gamma and e-beam radiation sterilization, to assure the adequate sterilization of products and instruments
• Chemical process indicators to monitor exposure to steam, ethylene oxide, gamma and e-beam radiation sterilization processes
• Culture Media
• Sterilization Packaging

While we offer a variety of consulting services, our core competency includes a wide range of testing services. All samples submitted to NAMSA for testing are handled according to the highest laboratory quality guidelines necessary to assure valid data. NAMSA chemists, microbiologists, toxicologists, veterinarians and other technical specialists review the data while representatives from our quality assurance department audit all forms of testing. Learn more about our testing services.

• Characterization of raw materials or components to assure reproducibility.
• Biocompatibility testing appropriate to the intended use of the component material or finished product.
• Microbial testing to identify and control the presence of microorganisms on the product and in the manufacturing environment.
• Product and process validation to confirm manufacturing controls meet quality assurance requirements and product specifications.
• Audit and release testing for finished products to assure product uniformity and compliance with label claims.

We provide access to information about the status of tests in progress and have built a reputation for quick turnaround times. All testing services are well documented according to strict protocols and clients receive results in a detailed NAMSA Laboratory Report.