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 ...
Medical devices are becoming increasingly connected to other devices, the Internet, or hospital networks to serve functions that improve healthcare and enhance treatment options. According to ...
On Thursday, the FDA Center for Devices and Radiological Health released updated final guidance for its Breakthrough Devices Program, aimed at verifying medical devices on the market are safe and ...
On January 6, 2024, FDA released draft guidance on Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations (the “draft guidance”). The ...
On January 7, 2025, FDA published a draft guidance titled “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations.” The draft guidance ...
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 ...
On May 29, 2025, the U.S. Food and Drug Administration (FDA) issued a final version of its guidance “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program,” ...
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