Understanding the Use of Cloud Computing as a Component of Regulated Medical Devices
A survey to inform future guidance for industry professionals
For more context on this survey, please refer to the companion blog post here:
If you have questions about this survey either before or after you take it, please email us at Cloud.Consensus@orthogonal.io
Your survey responses will be kept anonymous, unless you specifically authorize us to do otherwise.
Help us help you!
What kind of organization do you work for and what kinds of medical devices are you involved with? For example, please tell us:
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What is your job title and job function?
Are you currently using or considering/planning to use the cloud as a component of a regulated medical device in any of the following ways?
Currently Using
Considering/Planning Use
Not Using, Considering, or Planning Use
To perform the core clinical functions of a physical medical device (e.g., diagnostics, monitoring or therapeutics)
To perform secondary support functions for the physical device (e.g., service monitoring, logging, maintenance)
Electronic Quality Management System (QMS)
Clinical trials data management
Document or record control
Production management
Software development
Testing
Clear selection
For any Yes answers in the above grid, please provide us with some details about any of your current or future uses of the cloud as a component of a regulated medical device(s), including:
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If you selected "Not Using" for any of the above, please provide details on why not.
For a consensus report that provides guidance on the appropriate use of the cloud as a component of regulated medical devices:
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What do you see as the possible/proven benefits of using the cloud as a component of a regulated medical device?
What do you see as the challenges and risks of using the cloud as a component of a regulated medical device?
Do you manage cloud computing risks as a part of your device Risk Management Program? (e.g., PHA or DFMEA)
Is there anything we didn’t ask in this survey but should have?
If you would like to be added to our email list so that we can update you on the the development of this Consensus Report, you can provide your email address here:
Alternatively, you can be added to our email list but keep your email separate from your survey responses by sending an email to Cloud.Consensus@orthogonal.io
Thank you for your time, interest and support!
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