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On January 6, 2024, FDA released draft guidance on Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations (the “draft guidance”).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

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 ...