NAMSA evaluates the biological risk associated with a medical device product or material, as required by ISO 10993-1 (2009) and the EU Medical Device Directives. We look at predicates, materials, processes and composites to inform you of biological and toxicological hazards and regulatory implications, known and potential. We also recommend ways to mitigate risk, whether through testing or by establishing the safety of the materials and process.
We also evaluate biocompatibility appropriate to the intended use of the component material or finished product. These tests challenge various biological models with the test material or a suitable extract.
NAMSA’s specific safety programs follow FDA guidance and ISO 10993 standards. And our people work together—you’re likely to work with a team that 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.