{"product_id":"9783031528378","title":"Significant and Nonsignificant Risk Medical Devices","description":"\u003ch1\u003eSignificant and Nonsignificant Risk Medical Devices\u003c\/h1\u003e \u003ch2\u003eTimiri Shanmugam, Prakash Srinivasan; Thangaraju, Pugazhenthan; Sampath, Thamizharasan; Jagadeeswaran, Indumathy\u003c\/h2\u003e \u003cp\u003e\u003c\/p\u003e\u003cdiv\u003e\n\u003cdiv\u003eThis comprehensive resource explains the FDA's classification of devices and provides expert guidance on differentiating between significant risk and non-significant risk medical device studies. The book is divided into two parts: Significant Risk Medical Devices and Non-Significant Risk Medical Devices. Each chapter includes a general introduction and overview of the device, along with guidance on its working principles, beneficial and toxicological effects, and potential risks to the health and safety of a patient\/subject. The coverage also includes reports of prior investigations on the basics of risk determination and the nature of potential harm associated with using individual devices.\u003c\/div\u003e\n\u003cp\u003e\u003ci\u003eSignificant and Non-Significant Risk Medical Devices\u003c\/i\u003e is designed to assist practicing engineers, academic researchers, and clinical investigators in navigating the complex regulatory environment associated with medical device research and development.\u003c\/p\u003e\n\u003c\/div\u003e \u003ch3\u003eDetails\u003c\/h3\u003e \u003cp\u003ePublished by: Springer\u003c\/p\u003e \u003cp\u003ePublication Date: 2024-08-02\u003c\/p\u003e \u003cp\u003eFormat: Hardcover\u003c\/p\u003e \u003cp\u003eISBN-13: 9783031528378\u003c\/p\u003e \u003cp\u003eDOI: 10.1007\/978-3-031-52838-5\u003c\/p\u003e \u003cp\u003eDimensions: 235.0cm x155.0cm\u003c\/p\u003e \u003cp\u003ePages: 433.0\u003c\/p\u003e ","brand":"Springer Nature Switzerland","offers":[{"title":"Default Title","offer_id":44523442602124,"sku":"9783031528378","price":107.99,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0710\/9545\/1788\/files\/9783031528378.jpg?v=1763527834","url":"https:\/\/lateknightbooks.com\/products\/9783031528378","provider":"Late Knight Books and Services, LLC","version":"1.0","type":"link"}