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In April, FDA released a new draft guidance document on how to use the ISO 10993 standard for biocompatibility.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...
The appropriate Cleaning and Disinfection validations on reusable devices are extremely important to ensure safe for handling by health care personnel and to prepare reusable medical devices for additional reprocessing. ...
There’s a myriad of tests medical device manufacturers need to be prepared to conduct on their creations in order to pass regulation requirements before they are released to the marketplace....
