The Food and Drug Administration (FDA) partially recognized the ISO 10993 guidance making it one of the most important for the chemical … [Read more...] about Chemical Characterization Testing of Medical Devices

What is a Toxicological Risk? Toxicological risk measures the probability of an adverse effect being caused by a given compound. This covers … [Read more...] about An Overview of Toxicological Risk Assessments

One of the cornerstones of a biological evaluation process is chemical characterization. Chemical characterization testing is crucial for the … [Read more...] about The Role of Chemical Characterization Testing within a Biological Evaluation Process

A biological evaluation plan is developed to systematically assess whether a device intended for use in humans poses an unacceptable biological safety … [Read more...] about How to Develop a Biological Evaluation Plan

ISO 10993 comprises a series of international standards for the evaluation of biomedical devices and associated biological risk. ISO 10993 includes … [Read more...] about What is ISO 10993 Used for?