The reusable medical device industry is facing challenges regarding device design considerations and usability. The demand for more complex devices has led to the introduction of devices that are difficult...
Leachable and extractable studies have an increasing emphasis with biocompatibility. Manufactures are using the data to help supplement safety evaluations to the FDA. In the Innovation Brief we will go...
Most medical device manufacturers have defined acceptance criteria when it comes to the resistance of their biological indicators (BIs). The resistance of a BI can be determined by verification of...
In April, FDA released a new draft guidance document on how to use the ISO 10993 standard for biocompatibility. It is meant to eventually replace the current G95 document that...
There are currently a number of innovative activities in the world of radiation sterilization. This presentation will provide an overview of those activities which include irradiation of tissue/biologics/combination products, new...
