Software Medical Device Classification

gwolfe2208

Starting to get Involved
#1
My company has a "device" that is a software platform that hosts applications used by radiologists. The platform is used for account management and configuration and does import and export DICOMs. We currently have it classified as a Class I device for the EU. I am having doubts that it should even be considered a medical device. Our customers, hospitals, would use this platform that hosts the application that would be used with their PACs system to view images. The radiologist would then make their diagnosis based on their review. Does anyone have any thoughts?
 
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ECHO

Involved In Discussions
#2
Would you be able to elaborate more on your platform? Are these host applications and PACs Systems also developed by your company? Can these host applications and PACs System only work on your platform? What are these configurations that are adjustable on your platform?
 

gwolfe2208

Starting to get Involved
#3
the platform will host our application. Our clients use their own PACs systems using our platform that hosts our app. The app is software that provides standardized metadata descriptions of diagnostic medial images. It uses algorithms to analyze DICOM images to group exam series. The app we have classified as Class I. I am concerned about the platform that contains basic functionality like user access and security. It allows for integrations with third party PACs systems. Does this help?
 

gwolfe2208

Starting to get Involved
#6
Uhh..what is the "intended use" to be submitted to regulatory?
software platform that hosts applications related to various healthcare workflows, contains basic functionality such as user acces and security, and allows for integrations with other devices such as third-party PACs systems.
 
#7
Hello, i'm afraid the platform isn't a medical since it doesn't have a medical purpose defined by EU regulation as : "diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease "
 

ECHO

Involved In Discussions
#8
I am concerned about the platform that contains basic functionality like user access and security. It allows for integrations with third party PACs systems. Does this help?
Yes it is helpful, thanks.

I would think it is not a medical device.
If your platform is claiming to be compliant to certain standards, you will obviously have to meet those but from what I read, your platform is basically any OS system like Windows or Android.
 
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