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Whether an article on testing considerations, a catalog of standard studies, or an archive of a Webinar, our Resource Center is available for current and prospective customers to gain testing knowledge for successful implementation of testing programs.
Toxikon Medical Device Guide (1.62 mb)
Our Medical Device Testing Guide is an overview of testing requirements for standard ISO, MHLW, and USP compliant studies. The guide features directions for sample submission, test requirement matrix for FDA/ISO/Japanese guidelines, as well as test descriptions, estimated sample requirements, and turnaround times for individual studies.
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| Biocompatibility Safety Assessment of Medical Devices: FDA/ISO and Japanese Guidelines (143.75 kb)
Amid efforts at harmonization, important differences exist between U.S./FDA/ISO and Japan's Ministry of Health, Labour, and Welfare (MHLW) medical device biocompatibility requirements. Although the medical device market is extensive, Japan has been an exception to such harmonization efforts. Japan is an active participant in ISO standards setting, however, its written guidelines differ from those of the ISO/FDA in several important ways. This article identified the similarities and differences between ISO and MHLW, and describes how device-specific Japanese standards require some modifications from ISO 10993 in test procedures and protocols. |
| In Vitro Biocompatibility Testing: Safety Assurance for Complex Medical Devices (29.51 mb)
In the last several years, newly developed medical devices, such as atherectomy devices and embolization coils, have become increasingly more complex. As a result, the development of in vitro testing for cytoxicity and hemocompatibility has had to quickly adapt to accommodate the testing needs of these multifaceted devices. This presentation will provide a brief overview of biocompatibility assays for cytoxicity and hemocompatibility assays per ISO 10993 guidelines. |
| Preclinical Testing for the Ocular Industry (1.07 mb)
Ocular devices and drugs, such as viscosurgical devices and pharmaceuticals for macular degeneration and glaucoma, have experienced an expansion in their respective industries. With increasing need for these products, the industry has come to rely even more on efficacy and safety assessments. This presentation provides a brief overview of the in-vivo, in-vitro, and analytical chemistry testing required to advance these products into clinical use. |
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