The medical device development process is certainly not as simple as bringing an idea from the thought process through to production. There are many … [Read more...] about Understanding the Medical Device Development Process
We write blog posts on emerging and important aspects of analytical chemistry, focusing on lab-testing techniques.
Using Chemical Characterization Testing to Demonstrate Equivalency
Chemical characterization is a critical facet of the medical device pipeline. It is part of any quality-assured research and development (R&D) … [Read more...] about Using Chemical Characterization Testing to Demonstrate Equivalency
Biological Endpoint Testing in Biocompatibility Evaluations
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
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
