The Role of Biocompatibility Test Plans in Medical Device Approval
Ensuring a device’s safety for human use demands meticulous planning and thorough analysis, particularly regarding biocompatibility. At...
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What We Do
JL Tox Consulting provides consultation services related to toxicology and medical device biocompatibility. We have comprehensive knowledge of global medical device industry standards and regulations, including those set forth by the FDA, EU MDR, Japanese MHLW, and Korean MFDS. Our firm offers support in various areas such as biocompatibility, toxicology, and chemical characterization projects, as well as expertise in new product development, MDR and CAPA remediation, and lifecycle management. We provide a range of services including biocompatibility test plans, impact assessments, gap assessments, toxicological risk assessments, and biocompatibility evaluations. We have a proven track record of successfully guiding clients through the constantly evolving regulatory landscape of medical device biocompatibility.
Leading Experts in Toxicology and Biocompatibility for Medical Devices
Testimonials
“JL Tox Consulting has repeatedly and promptly provided to me medical device biological evaluations that were toxicologically-rigorous, consistent with ISO 10993 state-of-the-art, and creative to address a variety of biocompatibility scenarios and medical device business goals.”
Class II Medical Device Manufacturer
Industry Leading Toxicology & Medical Device Biocompatibility
Consulting Services
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