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"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.

Mark Cabonce, MSc, DABT
Medical Device Toxicologist
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