Biocompatibility Testing; what you need to know
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Website https://www.complianceonline.com/biocompatibility-testing-what-you-need-to-know-webinar-training-705 |
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Deadline: June 27, 2018 | Date: June 27, 2018
Venue/Country: online event, U.S.A
Updated: 2018-06-10 03:56:39 (GMT+9)
Call For Papers - CFP
All medical devices that have direct or indirect contact with the human body require an assessment of the biocompatibility of the materials used to manufacture the device, with the test schedule depending on the nature and duration of body contact. Domestic and international regulatory bodies are encouraging the use of risk-based approaches to assess biocompatibility rather than strictly following the specified testing matrix.The objective of the Webinar is to teach participants how to use ISO 10993-1 and FDA standards to establish a biological safety evaluation plan, including how to document and implement their plan. Participants will not only learn how to assess their device for biological risks but also understand when testing is not necessary.Areas Covered in the Webinar:Risk-based approach to Biocompatibility evaluation strategyOverview of ISO 10993-1Biocompatibility testing guidelines, costs, and turnaround timesLeachables and extractables (L&E) testing as an alternative to costlyTime-consuming long-term animal testing
Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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