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 ...

Engineers could avoid expensive redesigns by planning medical device testing early in development with expert guidance.

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 ...

Given the highly infectious nature of the COVID pathogen, tests for the virus had to be quick, reliable and safe. The test ...

U.S. and EU regulators require human factors and usability testing to bring a medical device to market. Virginia Lang, PhD, president and chief scientist at HirLan Inc., an engineering consultancy ...

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 ...