The integration of third-party components and software is an increasingly critical area of security risk that needs more attention from medical device manufacturers, says Anura Fernando, global head ...
Medtech developers incorporating AI or machine learning into medical devices need to recognize if and how FDA will regulate ...
On January 6, 2024, FDA released draft guidance on Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations (the “draft guidance”).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 ...
One of the most complex extended supplier networks is almost never on supply chain teams' radar: the mobile apps their ...
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