SMART quality & compliance
What is and what is not a Software as Medical Device (SaMD)
The pandemic lockdown has sped up digital transformation in this era. It is increasingly accepted that the availability of certain mobile or web-based apps have helped medical personnel better handle their jobs and allowed patients to access medical information or seek a medical solution more independently. However, when a topic revolves around medical affairs, it always comes with stringent scrutiny, leaving many software developers and manufacturers confused as to when the software is defined as a Software as Medical Device (SaMD) and how this differs from a conventional medical device? Clear guidelines have been developed by the International Medical Device…
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