Safety Assessment for Medical Devices and Combination Products- Brochure

The aim of this course is to review the principles of testing materials for biocompatibility. The full range of test methods will be discussed including chemical analysis, cell culture and other in vitro methods, acute animal studies including USP methods, thromboresistance, sensitization, long-term implant and other special studies. The nature of polymers and the sources of incompatibility will be discussed along with specific examples. Methods of testing will be related to the end use of a product. Examples of recommended testing programs will be presented, as well as the impact of FDA’s Good Laboratory Practice regulations and ISO requirements on preclinical testing of materials and medical devices.