{"product_id":"prakash-shanmugam-srinivasan-timiri-significant-and-nonsignificant-risk-medical-devices-9783031528408","title":"Significant and Nonsignificant Risk Medical Devices","description":"This 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. Significant and Non-Significant Risk Medical Devices is designed to assist practicing engineers, academic researchers, and clinical investigators in navigating the complex regulatory environment associated with medical device research and development.","brand":"Springer","offers":[{"title":"Default Title","offer_id":53731573727574,"sku":null,"price":0.0,"currency_code":"EUR","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0925\/5829\/5382\/files\/product_image_9783031528408_1.jpg?v=1781778835","url":"https:\/\/www.momoxbooks.com\/products\/prakash-shanmugam-srinivasan-timiri-significant-and-nonsignificant-risk-medical-devices-9783031528408","provider":"momoxbooks","version":"1.0","type":"link"}