Are you marketing a wireless, networked, or interconnected medical device in the United States? If so, you can expect intense regulatory scrutiny from the US Food and Drug Administration (FDA).
The FDA pays special attention to cybersecurity vulnerabililties in medical devices, and has established cybersecurity control requirements for network, wireless, and similar technologies. Manufacturers must take extra measures to ensure the cybersecurity of their device throughout its lifecycle. In this white paper, we address your biggest questions about US regulatory requirements for wireless medical devices, including:
We answer all of these questions and more in this 4-page white paper.
Residual risk analysis is a process whereby medical device and IVD manufacturers can integrate observed use errors into their design considerations
read moreHosted by the University of Illinois, this special webinar was developed to explain what non-medical manufacturers need to know to help alleviate s
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