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FDA has developed this guidance document to assist industry in following appropriate human factors and usability engineering processes to maximize the Draft Guidance for Industry and Food and Drug Administration Staff - Applying Human Factors and Usability Engineering to Optimize Medical Device Design. Contains Nonbinding Recommendations Draft - Not for Implementation Draft Guidance for Industry and Food and Drug Administration Staff Applying Human Factors and Usability Engineering to J Diabetes Sci Technol 2012;6(2):PAGE NUMBERS T Introduction he Food and Drug Administration (FDA) recently released draft guidance for applying human factors engineering and usability engineering (HFE/UE) to medical device design.1 When finalized, it will supersede its... The FDA issued a draft guidance document on ‘Applying Human Factors and Usability Engineering to Medical Devices to Optimize Safety & Effectiveness in Design’ for Управление по санитарному надзору за качеством пищевых продуктов и медикаментов (англ. Food and Drug Administration, FDA, USFDA) — агентство Министерства здравоохранения и социальных служб США, один из федеральных исполнительных департаментов. when finalized, will represent the Food and Drug Administrations (FDAs) current thinking on this topic. Usability of FDA-Approved Medication Guides. Michael S. WolfAffiliated withHealth Literacy and Learning Program, Division of www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM07055 1.pdf. 6 Guidance on the Content of 510(k) submissions On Wednesday, the Food and Drug Administration (FDA) published the long awaited Applying Human Factors and Usability Engineering to Medical Devices guidance document. Информация взята v3.kz |
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