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Medical Device Testing

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 any 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 meet current global standards.

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

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 the biocompatibility component, but also multiple other 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 testing team is comprised of various experts, readily available to evaluate your device. These teams include chemists, material specialists, toxicologists and biocompatibility testing experts. Together, we can ensure that your safety evaluation plan minimizes unnecessary testing, maintains compliance with all pertinent standards and regulations and provides evidence for the ultimate goal of proving product safety.

NAMSA’s biocompatibility tests challenge various biological models with test materials or suitable extracts. Specific safety programs follow FDA guidance, ISO 10993 standards 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
  • Reproductive/Developmental Testing
  • Sensitization Testing
  • Subchronic Toxicity Testing

NAMSA also works with global clients to personalize biocompatibility 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 encompass our biological safety consulting services. Our process includes everything from creating a biological evaluation plan to creating gap analyses and adverse test result memos if needed. It’s our commitment to move the testing process along with great care while respecting your timelines.

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