On January 6, 2024, FDA released draft guidance on Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations (the “draft guidance”).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 ...

Over the years, medical device design experts have contributed to MD+DI in a variety of ways, including participation in the judging of the Medical Design Excellence Awards (MDEAs) and speaking at our ...

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 ...

The FDA formally kicked off its quinquennial process to reauthorize the federal user fee legislation that helps fund its medical device reviews by hosting discussions with the medtech industry and ...