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FDA guidance

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Journal Articles
AM&P Technical Articles (2021) 179 (3): 52–55.
Published: 01 April 2021
...Matthew Di Prima; David Saylor; Shiril Sivan; Jason D. Weaver New FDA guidance for Nitinol used in medical devices includes clarification on the determination of safety factors, the requirements for corrosion testing, and proper labeling of potentially harmful elements. Copyright © ASM...
Journal Articles
AM&P Technical Articles (2013) 171 (4): 32–33.
Published: 01 April 2013
...- ical device industry specifically in which SIMULIA actively participates together with other companies in the field. As one outcome of these efforts, the FDA will publish a guidance document entitled Reporting Computational Mod- eling Studies in Medical Device Regula- tory Submissions in 2013...
Journal Articles
AM&P Technical Articles (2023) 181 (7): 40–42.
Published: 01 October 2023
..., disability, or death. To aid in assessing Nitinol device durability, researchers from Medtronic, Boston Scientific, and the U.S. Food and Drug Administration (FDA) have been measuring and modeling Nitinol fatigue. Though additional experiments are still in progress, scientists are beginning to publish...
Journal Articles
AM&P Technical Articles (2020) 178 (7): 22–23.
Published: 01 October 2020
... America Makes quickly recognized the importance of coordinating these efforts, collaborating with the Department of Veterans Affairs (VA), Food and Drug Administration (FDA), and National Institutes of Health (NIH) (see Fig. 1) to mobilize the AM community to address medical equipment shortages...
Journal Articles
AM&P Technical Articles (2019) 177 (8): 22–23.
Published: 01 November 2019
... of results and raw data to a larger LIMS. DATA INTEGRITY Whether a materials testing professional is in the medical device, aerospace, food testing, automotive, or pharmaceutical industry, data integrity and results validation is constantly under a microscope. FDA 21 CFR Part 11, ISO/IEC 17025, and NADCAP...
Journal Articles
AM&P Technical Articles (2018) 176 (6): 67–79.
Published: 01 September 2018
... position. I understand the need and usefulness of it as it pertains to law, but coming from engineering where you get to list the assumptions as givens, it was incredibly tedious. What are you working on now? I m currently working on implementing a quality management system (QMS) for a company in an FDA...