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-l

chapter 1|6 pages

Introduction /

chapter 3|22 pages

Road Map to Test Selections /

chapter 4|14 pages

Materials in Medical Device Design /

chapter 6|6 pages

Cytotoxicity Testing /

chapter 7|8 pages

Hemocompatibility /

chapter 8|16 pages

Local Tissue Tolerance /

chapter 9|34 pages

Immunotoxicology /

chapter 10|10 pages

Implantation Biology and Studies /

chapter 12|30 pages

Genotoxicity /

chapter 14|6 pages

Carcinogenicity /

chapter 15|20 pages

Degradation Products and Impurities /

chapter 16|8 pages

Combination Products /

chapter 17|12 pages

Clinical Studies for Medical Devices /

chapter 18|12 pages

Special Studies /

chapter 20|14 pages

Case Histories and Problem Resolution /