The medical device industry has long been interested in techniques for predicting the shelf life of polymer-based devices. This year, that interest will increase substantially. As of June 14, 1998, the European Union is banning the sale of sterile...
Testing for cytotoxicity is a good first step toward ensuring the biocompatibility of a medical device.
Equipment News: Testing and inspection
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Whatever the goal, the design of an efficient and successful medical device clinical trials program will almost always involve the use of pilot studies.
