July 7, 2022
The following poster was presented at the Extractables & Leachables session of the annual conference of American Society for Mass Spectrometry (ASMS) in Minneapolis. Read the following abstract to learn more. Routine E&L testing of medical devices requires extraction using...
See BlogMarch 21, 2022
Six steps to assess the situation and determine how to move forward… Each medical device present or coming on the market needs to have a demonstrated biocompatibility to protect users from potential biological risks arising from its intended clinical use....
See BlogDecember 7, 2021
Understanding the sterility assurance level To understand how steam sterilization processes are validated, it is important to understand some key concepts about sterilization. The purpose of sterilization is to inactivate microbiological contaminants, thereby rendering products sterile[1]. The kinetics of inactivation...
See BlogNovember 30, 2021
ISO 17664:2017[1] as well as FDA[2] state that if a medical device is intended to be sterilized, at least one validated sterilization method must be specified in the IFU. Consequently, if devices are intended to be steam sterilized, at least...
See BlogJune 18, 2021
On May 20, 2021, FDA published a document (“Safety of Metals and Other Materials Used in Medical Devices”) requesting input regarding the best methods to use in conveyance of material information for a broader range of medical devices to both...
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