Some of the most challenging leakage-current-testing requirements are those for patient-monitoring devices—both invasive and noninvasive. Such testing can be time-consuming and expensive, so it is ...
Medical device manufacturers use cytotoxicity testing to help prove that devices that come into contact with the human body are biocompatible. Testing results are critical for gaining market access, ...
As data-driven innovation profoundly changes every industry, the healthcare sector is also affected. Digital twins – virtual copies of physical devices – are essentially changing the ...
US medical device regulators have announced more than 30 new additions to their list of recognized device consensus standards. In a Federal Register announcement on 9 July 2014, the US Food and Drug ...
Changes affecting the approval of medical devices in Canada are coming. Health Canada has released a notice on Proposed Changes to the Guidance on Recognized Standards for Medical Devices along with a ...
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