December 7, 2022
Understanding the differences between how devices are used in a clinical setting is the key to a successful validation. It is important to create a roadmap of the device you wish to validate from patient use to storage. This information...
See BlogDecember 7, 2022
For the past three to four decades, biocompatibility testing has stayed relativity unchanged; you follow a few simple steps: 1) look at your device 2) compare it to a chart 3) do the suggested testing. With the recent publication of...
See BlogMay 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...
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