Recent developments in 3D printing materials allow for better simulation of human anatomy, not only in shape but also in how tissues appear in medical imaging such as X-rays and CT scans. RadioMatrix, ...
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 ...
Medtech developers incorporating AI or machine learning into medical devices need to recognize if and how FDA will regulate ...
Medical device design and development is a process that helps to ensure devices that go to market are safe, effective, marketable, and profitable. The process is a blueprint of the phases needed to ...
Designers and engineers have often looked to the environment and how Mother Nature has accomplished phenomenal design solutions for inspiration over the ages. Perhaps all that is new about this ...
The tension between safety considerations and user experience design (UXD) in the medical device industry reflects broader regulatory and market pressures. When designing and developing medical ...
Join RAPS Boston for an in-depth session unpacking the real world regulatory playbook for AI-enabled wearable devices, from first submission to post-market evolution. Learn from industry leaders ...
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