美国FDA 法规 医疗器械中的人为因素导论 An Introduction to Human Factors in Medical Devices.pdfVIP

Do It By Design FOREWORD The Center for Devices and Radiological Health (CDRH), part of the Food and Drug Administration (FDA), develops and implements national programs and regulations to protect the public with respect to devices and radiological health. These programs are intended to assure the safety, effectiveness, and proper labeling of medical and radiation-emitting devices. An emerging concern of great importance to the Agency is th