cybersecurity

  1. Marcelo Antunes

    Medical Device News FDA Releases Draft Recommendations on Premarket Submissions for Management of Cybersecurity in Medical Devices

    FDA Releases Draft Recommendations on Premarket Submissions for Management of Cybersecurity in Medical Devices Eloqua - Content of Premarket Submissions for Management of Cybersecurity in Medical Devices FDA - Content of Premarket Submissions for Management of Cybersecurity in Medical Devices
  2. Marcelo Antunes

    Medical Device News IMDRF update - 26-09-18 - Cybersecurity, Premarket Reviews, Personalized Devices

    IMDRF Takes Up Cybersecurity, Premarket Reviews, Personalized Device Pathways IMDRF Takes Up Cybersecurity, Premarket Reviews, Personalized Device Pathways | RAPS
  3. Marcelo Antunes

    Medical Device News FDA news -11-09-18 - Review of Cybersecurity into Premarket Review

    U.S. Department of Health & Human Services Office of Inspector General report: FDA Should Further Integrate Its Review of Cybersecurity Into the Premarket Review Process for Medical Devices https://oig.hhs.gov/oei/reports/oei-09-16-00220.pdf
  4. R

    Training in Cyber Security

    I own a small organisation in Quebec, we are getting security services from the NCI, Quebec. We don't have any security developer to monitor the security performances. I am much interested in cyber security, I would like to know about cyber security in detail. But I am little confused whether to...
  5. R

    Medical Device Cyber Security Third Party Review

    Hello, I was hoping to get some input on what services (certification agencies) are out there for a medical device manufacturer to get a cyber security review and certification, if possible. Also what would such a review entail? Thanks!
  6. R

    Cybersecurity for Medical Devices and Hospital Networks

    http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm356423.htm?source=govdelivery The draft guidance for premarket submissions can be found here: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm356186.htm?source=govdelivery
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