Safely Introducing New Surgical Devices in Minimally Invasive Gynecologic Surgery: An Argument for Use of the IDEAL Framework.

Ramanathan, Aparna; Davis-Cooper, Shelby; Iglesia, Cheryl B

Ramanathan, Aparna; Davis-Cooper, Shelby; Iglesia, Cheryl B.

Afiliação

Ramanathan A; National Center for Advanced Pelvic Surgery, Medstar Washington Hospital Center, Department of Gynecology and Obstetrics, Georgetown University School of Medicine, Washington, District of Columbia (all authors).
Davis-Cooper S; National Center for Advanced Pelvic Surgery, Medstar Washington Hospital Center, Department of Gynecology and Obstetrics, Georgetown University School of Medicine, Washington, District of Columbia (all authors).
Iglesia CB; National Center for Advanced Pelvic Surgery, Medstar Washington Hospital Center, Department of Gynecology and Obstetrics, Georgetown University School of Medicine, Washington, District of Columbia (all authors).. Electronic address: cheryl.iglesia@medstar.net.

J Minim Invasive Gynecol ; 31(1): 21-27, 2024 01.

Article em En | MEDLINE | ID: mdl-37866715

Assuntos

Aprovação de Equipamentos; Laparoscopia; Estados Unidos; Feminino; Humanos; Procedimentos Cirúrgicos Minimamente Invasivos; Laparoscopia/métodos; United States Food and Drug Administration; Procedimentos Cirúrgicos em Ginecologia

Palavras-chave

IDEAL framework; Innovation; Manufacturer and User Facility and Device Experience database; Regulatory approval; Surgical instruments

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Texto completo: 1 Bases de dados: MEDLINE Assunto principal: Laparoscopia / Aprovação de Equipamentos Limite: Female / Humans País/Região como assunto: America do norte Idioma: En Revista: J Minim Invasive Gynecol Assunto da revista: GINECOLOGIA Ano de publicação: 2024 Tipo de documento: Article

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