The FDA just issued a Safety Communication on cybersecurity vulnerabilities of the Hospira Symbiq Infusion System. The Hospira Symbiq Infusion System is a computerized pump designed for the [...]
Blog Home TAG: IT Security
In Archives, Medical Device Industry, FDA Regulated Industries, Pharmaceutical Industry, Regulatory Compliance ManagementPosted
Informed consent (IC) is more than getting a quick signature from a clinical trial participant, the FDA gently reminds industry in a new guidance addressing increasingly complicated electronic IC [...]
As more physicians are integrating their patient EMR with third-party patient portals, they’re looking for clarifications on many issues in order to stay within the various regulations boundaries [...]
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