Biological safety evaluations are designed to assess whether a product is safe for its intended use depending on its composition. For example, an … [Read more...] about Biological Endpoint Testing in Biocompatibility Evaluations
Read our blog posts on analytical chemistry lab testing and how it helps companies answer polymer questions.
Chemical Characterization Testing of Medical Devices
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
An Overview of Toxicological Risk Assessments
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
The Role of Chemical Characterization Testing within a Biological Evaluation Process
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
How to Develop a Biological Evaluation Plan
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
