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NASMA first to receive FDA ASCA Accreditation
Congratulations to NAMSA for being the first medical device CRO to receive FDA #ASCAAccreditation for Medical Device Biocompatibility...

JL Tox Consulting
Aug 17, 20211 min read


NuVasive MAGEC system components recall highlights importance of Biocompatibility
One of the most unique aspects of medical device #biocompatibility is just how quickly your work can have a direct impact on patients....

JL Tox Consulting
Jul 26, 20211 min read


CTSS Webinar: Moving from One-Size-Fits-All to Fit-for Purpose TTC Values
Excited for this one by the Computational Toxicology Specialty Section of the Society of Toxicology (SOT). The applicability of the TTCs...

JL Tox Consulting
Jul 22, 20211 min read


FDA Partially Recognizes ISO 10993-23:2021
On June 7th, the U.S. FDA partially recognized ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation...

JL Tox Consulting
Jun 20, 20211 min read


Medical Device Biocompatibility – Toxicological / Biological Safety Assessments
Michael Song, Ph.D., AstraZeneca, provides an overview of medical device biocompatibility. See the full article here:...

JL Tox Consulting
Apr 6, 20211 min read


NAMSA acquires American Preclinical Services
Contract research organization NAMSA announced its acquisition of Minneapolis-based American Preclinical Services (APS). Read more here:...

JL Tox Consulting
Apr 5, 20211 min read


New Regulations, New Timelines: How Chemistry Changed in Response to ISO 10993-18:2020
Sandi Schaible, Senior Director of Analytical Chemistry and Regulatory Toxicology at WuXi Medical Device Testing, discusses the changes...

JL Tox Consulting
Feb 1, 20211 min read


Biocompatibility Evaluation of Breathing Medical Devices: Understanding ISO 18652
James Lyons, PhD, Principal Consultant JL Tox Consulting, LLC provides an overview of the ISO 18562 series of international standards...

JL Tox Consulting
Jan 12, 20211 min read
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