Laboratory-based design verification testing (DVT) of combination products and medical devices must be performed to demonstrate that the device meets the performance requirements that were set in the ...
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 ...
Regulators increasingly want medical device manufacturers to begin with a more precise understanding of their product's ...
In the medical device industry, usability plays a critical role in ensuring the safety and effectiveness of highly complex medical products. The IEC 62366-1:2015 standard, which focuses on the ...
AUSTIN, Texas--(BUSINESS WIRE)--atsec AB Stockholm, Sweden is thrilled to announce: We are the first IEEE Authorized Testing Facility! We've officially been approved as an IEEE Authorized Testing ...
System-level testing is becoming essential for testing complex and increasingly heterogeneous chips, driven by rising demand for reliable parts in safety- and mission-critical applications. More and ...
WuXi AppTec is parting ways with its U.S. medical device testing business, selling its two stateside locations to the Ohio-based regulatory consulting firm NAMSA. The deal includes facilities in ...
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