May 27, 2022
Manufacturers are often advised to perform an extractables study after completing a biological evaluation of their medical devices, a procedure that is very well described in ISO10993-18. The standard includes guidance regarding how the extractions need to be performed, how...
See BlogMay 27, 2022
Ethylene oxide sterilization is a well-established sterilization technology, utilized to sterilize approximately 50% of all medical devices in the United States annually. Despite comprehensive, complex, and extensive validations, some failures may occur during routine processing. It is important to conduct...
See BlogMay 27, 2022
Every medical device needs to have proven biocompatibility to protect users from potential biological risks arising from its intended use. In particular, cytotoxicity must be evaluated for every medical device, regardless of its classification. Cytotoxicity testing is often conducted using...
See BlogMay 5, 2022
Fallout from the COVID-19 pandemic continues to ripple through our global economy. Quarantine and changing work environments have caused employees to reevaluate their roles, leading to the great resignation. Supply chain disruptions have caused cascading issues and delays. As in...
See BlogFebruary 23, 2022
Blood-contacting devices must be assessed to understand how the interactions of the device with the patient’s blood do not pose a safety risk to the patient. What are some tests that need to be considered for a hemocompatibility assessment? What...
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