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 ...
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 ...
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 ...
On July 31, 2025, the U.S. Food and Drug Administration (FDA) issued its final guidance document “Medical Device User Fee Small Business Qualification and Determination,” which supersedes its previous ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results