Does IVD need to integrate with hospital IT infrastructure?

ECHO

Involved In Discussions
Hello,

Today, I was told by a few stakeholders that our IVD device needs to integrate with a hospital's Laboratory Information System.
Our system doesn't require any information other than the sample to run, so I am trying to understand if this is a requirement based on a standard or if this is a "nice to have" feature.

I am new to the IVD space and I would appreciate some guidance and maybe even a reading list for me to get started.

Thank you in advance.
 

normhowe

Involved In Discussions
Hello,

Today, I was told by a few stakeholders that our IVD device needs to integrate with a hospital's Laboratory Information System.
Our system doesn't require any information other than the sample to run, so I am trying to understand if this is a requirement based on a standard or if this is a "nice to have" feature.

I am new to the IVD space and I would appreciate some guidance and maybe even a reading list for me to get started.

Thank you in advance.
It's not a regulatory requirement. But if the customer requires it, it's not just 'nice to have'. IEC 62304 is the guidance for embedded software in devices.
 

Tidge

Trusted Information Resource
Today, I was told by a few stakeholders that our IVD device needs to integrate with a hospital's Laboratory Information System.

One word of caution: Health Delivery Organizations are making very serious reviews of all medical device software that interfaces with any other systems at the HDO, because of cybersecurity.

The stakeholders referenced should be external to your organization and should include both clinical/laboratory folks but also the folks responsible for cybersecurity at the potential customers. Satisfying both groups is not an insurmountable problem. If the stakeholder needs were expressed by internal resources, I would have a conversation with those folks regarding MDS2 forms, starting with "who fills these out?".
 
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