In the United States, medical devices are regulated by the FDA. In the European Union, medical devices are...
SaMD
Regulating Software
Medical devices have advanced beyond the point of simple machinery. Software has begun playing an important...
Global Regulators publish Good Machine Learning Practices (GMLP)
It is no secret that AI/ML medical devices are under a special spotlight by international regulators this...
Digital Health: The New Wave of Medicine
New digital health technology is coming out every day and is changing the course of the MedTech industry as we know...
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