Cybersecurity is and will be a hot topic in the medical devices field for a long time, as more and more devices are connected. Health Canada (together with the US FDA) are two of the regulatory bodies more concerned with this topic. Here is a link to a recent consultation on a guidance document...
Greetings fellow Covers,
I'm beginning a new job at a law firm. Right now, we are small but we have big clients and I think it would add some value to start working towards IT security standards. But I have no idea where to start. For my last job, I walked into a ISO 13485, ISO 9001 certified...
Hi everyone, I'm trying to get an idea of what this new FDA draft - "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" (Document issued on October 18, 2018) implies for our company and our new designs.
The way I see it is that medical devices with complex User...
Office of Inspector General of the U.S. Department of Health & Human Services (HHS) - The Food and Drug Administration's Policies and Procedures Should Better Address Postmarket Cybersecurity Risk to Medical Devices
Full Report - https://oig.hhs.gov/oas/reports/region18/181630530.pdf
In a risk analysis, how can we tie security breach (e.g. losing confidentiality of patient information) to ISO 14971? What is the severity level of harm for loss of confidentiality of information in a mobile app? I would think we should do that exploitability analysis first as per...
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
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
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...
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!
The draft guidance for premarket submissions can be found here: