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Testing Service Category: Testing Service Child Post

September 28, 2018

Study Design

Understanding Biocompatibility in a Risk Management Context As part of a biocompatibility evaluation, ToxSmart reviews the design and intended use of a medical device, as well as the previous biocompatibility data for the device or a similar device. Based on this assessment, we provide our recommendations for completion of the biological safety evaluation, which may […]

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September 28, 2018

Regulatory Strategy

Understanding Regulatory Review  Program success is determined by satisfying the regulatory review who have demands that are shaped by key opinion leaders (KOLs). ToxSmart stays current with trends in regulatory guidance through frequent communication with these thought leaders; this often leads to positive, science-driven interactions with regulatory agencies. Our subject matter experts can help you […]

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September 28, 2018

Gap Analysis

Understanding Gap Analysis Life science product developers want to ensure that their historic testing results are still compliant with contemporary testing standards. Manufacturers may also want to verify that their testing program is complete for the classification of their device. Gap analysis helps them maximize the use of historical data and refine their current testing […]

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September 28, 2018

Toxicological Risk Assessment (TRA)

Understanding Toxicological Risk Assessment (TRA) TRA is a research-based evaluation comprised of four activities: hazard identification and data evaluation exposure assessment dose-response analysis risk characterization The risk assessment is based on a chemical characterization of the test article, published information from the toxicological literature, and tolerable exposure limits, which may be adopted from published guidelines […]

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September 28, 2018

Microbiology Custom Studies

Customized Testing for Innovative Medical Products The diverse scientific capabilities within the department are leveraged appropriately to address each unique product requirement. With the emergence of complex devices, such as combination products, our team has become recognized by the industry as a valuable resource in developing early stage screening studies to product and validation studies. [...] Full Story

September 28, 2018

US FDA CFR Testing

Understanding CFR Testing The purpose of the study is to analyze total extractables. Extract solutions are evaporated to dryness and residues are weighed. Residue per surface area is calculated. Testing categories and specifications Test NameSample NeededTurn-Around Time Total Extractables - Rubber Articles Intended for Repeated Use, CFR 177.2600150 cm²/extract2-3 weeks Full Story

September 28, 2018

European Pharmacopoeia Testing

Understanding EU Regulatory Guidance for Pharmaceuticals The purpose of the tests is analyzing for relative differences in visual appearance, acidity/alkalinity, reducing substances, relative density, volatile matter, mineral oil, substances soluble in hexane, phenylated compounds, optical absorbance additives, and extractable heavy metals. 3.1 Series; Materials used in the Manufacture of Pharmaceutical Containers The materials described in [...] Full Story

September 28, 2018

Japanese Pharmacopoeia Testing

Understanding Japanese Regulatory Guidance for Pharmaceuticals The purpose of the study is to determine content of inorganic impurities in an organic substance. Testing categories and specifications Test NameSample NeededTurn-Around Time Residue on Ignition, USP5 grams2-3 weeks Full Story

September 28, 2018

Device Implantation

Understanding Implantable Device Testing Services Implantation tests are in-vivo assays used to assess the local pathological effects on living tissue, at both the gross and microscopic level of a test article that is implanted into an appropriate implant site. Standard implant sites include muscle, bone, subcutaneous, intraperitoneal, and brain. The assay is typically performed in [...] Full Story

September 20, 2018

Support Services

State of the art facilities with comprehensive surgical support services. Our facilities offer the capabilities to handle large and small animal models. Alongside our two vivariums, our fully equipped surgical and procedure spaces offer the latest in surgical equipment, monitoring, and imaging. Toxikon’s special support services can provide full hematological assessments, biochemistry, analytical, and histopathology […]

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