A medical device is an umbrella term for any instrument, software, or other article used alone or in combination for a medical purpose in humans. An estimated 2 million different kinds of medical ...
Many medical device companies develop software using a traditional waterfall methodology in which each step is taken in sequence: requirements, design, implementation, verification, and validation ...
When the Federal Drug Administration (FDA) updated the provisions for medical device cybersecurity, one of those required the development of a software bill of materials (SBOM). It’s now mandatory for ...
The FDA has entered into the federal register a new draft guidance pertaining to "software as a medical device" (SaMD). The guidance is presented as representing the FDA's current thinking on ...
On January 6, 2024, FDA released draft guidance on Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations (the “draft guidance”).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 ...
As the world’s medical device regulators work to harmonize how best to regulate software as a medical device (SaMD), MobiHealthNews has learned via a Freedom of Information Act request that the FDA ...
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