JL Tox Consulting
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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JL Tox Consulting
Oct 153 min read
Chemical Characterization Consulting Services: Regulatory Insights
Chemical characterization consulting services are a pivotal element in the development and approval of medical devices.
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JL Tox Consulting
Sep 163 min read
How to Ensure Medical Device Biocompatibility
JL Tox Consulting can help you prepare a medical device biocompatibility safety evaluation to achieve regulatory success.
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JL Tox Consulting
Aug 123 min read
Why Invest in Medical Device Consulting Services?
When it comes to manufacturing medical devices, ensuring safety and compliance is paramount. Navigating complex regulatory landscapes can...
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JL Tox Consulting
Jul 152 min read
How Toxicological Risk Assessments Work
Professional toxicological risk assessments are a cornerstone of ensuring the safety of medical devices.
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JL Tox Consulting
Jun 152 min read
Benefits of Biocompatibility Test Plans for Medical Devices
Biocompatibility test plans are crucial to ensuring that medical devices are safe and compliant for patient use.
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JL Tox Consulting
May 152 min read
What Are Chemical Characterization Consulting Services?
What exactly are chemical characterization consulting services, and why do you need them?
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JL Tox Consulting
Nov 2, 20232 min read
Why is Medical Device Regulatory Consulting Essential for Product Approval?
The regulatory landscape for medical devices is evolving rapidly, and ensuring compliance with the set regulatory standards is vital for...
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JL Tox Consulting
Oct 26, 20232 min read
What Does Medical Device Biocompatibility Testing Involve?
Designing, manufacturing, and seeking registration for medical devices requires strict compliance with the set regulations. The...
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JL Tox Consulting
Oct 18, 20232 min read
What are the Key Benefits of Medical Device Consulting?
Today, from diagnosis to management of diseases, in vitro diagnostics (IVDs) and medical devices play a significant role. To ensure the...
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JL Tox Consulting
Oct 12, 20232 min read
How Does Toxicology and Medical Device Biocompatibility Consulting Elevate Product Excellence?
As it is with every other health product, the quality, safety, and efficacy of a medical device must be built into the product. Achieving...
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JL Tox Consulting
Aug 17, 20211 min read
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...
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JL Tox Consulting
Jul 26, 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....
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JL Tox Consulting
Jul 22, 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...
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JL Tox Consulting
Jun 20, 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...
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JL Tox Consulting
Apr 6, 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:...
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JL Tox Consulting
Apr 5, 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:...
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JL Tox Consulting
Feb 1, 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...
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JL Tox Consulting
Jan 12, 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...
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