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 ...
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 ...
Remaining competitive in the medical device market requires the ability to improve quality while reducing costs. Sartorius offers various solutions to improve productivity and meet rigorous compliance ...
Taking a proactive approach to compliance can help minimize regulatory risks, avoid submission delays, and ensure continued ...
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 ...
Understanding how packaging levels interact and support overall package integrity is critical for ensuring regulatory ...