Testimonials
"I consider myself fortunate to count JL Tox Consulting as a Medical Device Toxicology Colleague for the past 6 years. We have consulted with one another on numerous occasions regarding biocompatibility strategies within the framework of ISO 10993-1:2018 Evaluation and testing within a risk management process and FDA: 2020 Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing"
I have always been impressed with his in depth knowledge of the current standards, especially ISO10993-18:2020 Chemical characterization of materials and chemical risk assessment and ISO10993-17:2002 Establishment of allowable limits for leachable substances. His broad experience with in vitro/in vivo biocompatibility, chemical characterization, and toxicological risk assessment are demonstrated in his practical approach to biocompatibility strategies and defense. He applies this expertise while still keeping regulatory acceptability as a primary target. However, and most importantly, James never loses site of his primary goal – patient safety. In my experience with James, his most important decisions have always been based on providing the right data to support patient safety. He is a true asset for those seeking his consult to minimize regulatory hurdles but maximize patient safety.