Navigating Healthcare Cybersecurity: Section 524B of the FD&C Act
In our interconnected world, where medical devices are integral to patient care, cybersecurity stands as a paramount concern. The Food and Drug Administration (FDA), recognizing the…
Medical Device Cybersecurity
Recommended Practices for Software-Contained Device Manufacturer Why Cybersecurity for Medical Devices? As more medical device software is released to the market, information exchange and integration between…
MedTech Software Verification and Validation
Over the past decade, interest in innovating and commercializing medical devices has significantly increased. In the current trend of MedTech, Software as a Medical Device (SaMD)…