Capturing the growth of the global medical device market in recent years, this practical new guide is essential for all who are responsible for ensuring safety in the use and manufacture of medical devices. It has been extensively updated to reflect significant advances, incorporating combination products and helpful case examples of current real-life problems in the field. The Third Edition explores these key current trends: global device markets continually advancing technology the increasing harmonization of device safety regulation worldwide Each aspect of safety evaluation is considered in terms of International Standards Organization (ISO), US Food and Drug Administration (FDA), European Union (EU), and Japanese Ministry of Health and Welfare (MHW) perspectives. In addition, the book reflects the role of the continuing growth of technology in the incorporation of science, particularly in the areas of immunotoxicology and toxicokinetics.Model experimental system for investigation of heart valve calcification in vitro. ... Tissue response to polyglycolide, polydioxanone, polylevolactide, and metallic pins in cancellous bone: An experimental study on rabbits. ... Characterization of Biological Indicators for Gamma Irradiation, In: Proceedings of the Third PMA Seminar on Validation of ... Sterilization of Medical Devices (1982), Program 7378.008A, FDA Compliance Program Guidance Manual, FDA, Rockville, MD, August.
|Title||:||Safety Evaluation in the Development of Medical Devices and Combination Products, Third Edition|
|Author||:||Shayne C. Gad, Marian G. McCord|
|Publisher||:||CRC Press - 2008-10-20|