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FDA’s take on Digital Health Regulatory Paradigm Shift
In recent years, the medical device industry has become overwhelmingly impacted by digital health. According to the US Food and Drug Administration (FDA), products that fall…
Understanding The New Requirements for QMS Software Validation in ISO 13485:2016
As I am sure many of you know, the ISO 13485 standard was updated in 2016, which means the time to transition your Quality Management System…