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Medical Device Testing

GLOBAL Biocompatibility Testing for Medical Devices



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In Vitro and In Vivo safety evaluation studies are conducted on a variety of biomaterials, medical devices and related products to identify the presence of toxins or other potentially harmful effects. Biocompatibility testing for medical devices ranges from initial screening of new materials to product release testing and non-clinical or pre-market safety evaluations to ensure your device meets current global standards.

At NAMSA, we understand the confidence you require in your biocompatibility testing partner to deliver high-quality, accurate results on your way to commercialization. Our highly trained experts perform all tests in house to evaluate your device’s component material / finished product use and regulatory pathway — minimizing cost and development time.

NAMSA has over 50 years of experience providing biocompatibility testing services worldwide. That equates to unparalleled support for sponsors in the United States, United Kingdom, Ireland, Spain, France, Germany and many other countries worldwide.

The biocompatibility of medical devices, directed by ISO 10993-1, is a critical part of the medical device risk management process. Commonly referred to as biological safety, this evaluation of risk consists of multiple mechanisms that work together to accurately predict medical device biocompatibility based on individual materials and use. The use of biological evaluation plans, chemical characterization testing, biocompatibility testing and toxicological risk assessment are all necessary components of the successful mitigation of biological risks.

NAMSA’s medical device biocompatibility testing team is composed of chemists, material specialists, toxicologists and other testing experts who work together to ensure your safety plan minimizes unnecessary testing, maintains compliance and provides evidence of device safety.

NAMSA’s biocompatibility tests challenge various biological models with test materials or suitable extracts. Specific safety programs follow FDA guidance, ISO 10993 standards — including ISO 10993-1 — and other international guidelines.

Primary test categories used to determine biological effect include:

  • Acute Systemic Toxicity Testing
  • Biodegradation Testing
  • Carcinogenicity Testing
  • Chronic Toxicity Testing
  • Cytotoxicity Testing
  • Genotoxicity Testing
  • Hemocompatibility Testing
  • Implantation Testing
  • Intracutaneous Irritation Testing
  • In Vitro Irritation Testing
  • Reproductive/Developmental Testing
  • Sensitization Testing
  • Subchronic Toxicity Testing

NAMSA also works with global clients to personalize biocompatibility testing programs to most effectively meet development, regulatory and business objectives.

Ensuring biological safety is an extremely rigorous process, and our team works to achieve compliance through several steps that are encompassed our biological safety consulting services. Our process includes everything from creating a biological evaluation plan to gap analyses and adverse test result memos when needed. It’s our commitment to move the testing process along with great care while respecting your timelines.

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