Regulatory strategy for Third party plugin in a PACS

#1
Hi all,

We are developing a third party plugin that will be integrated within a PACS. We are of course compliant with IEC 62304 harmonized standard requirements for the development of our plugin, which can also be use as a standalone application.
Our question is: Do we have specific regulatory requirements for our plugin?
- Are we solely responsible for this integration to demonstrate the safety and effectiveness of our plugin?
- Should we demonstrate that we do not impact safety and effectiveness of the PACS?
- Should we contact the PACS to perform a kind of qualification/validation?
- Any other things to do?

Note that our plugin execute our AI specific algorithm onto the images displayed by the PACS. Of course, the original IFU of the PACS is no more the same but because of our plugin only.

Does anyone have an idea?

Best
Sly
 
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shimonv

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#2
Hi Sly,
Sounds like a cool app.
The answers below are based on the assumptions that the plugin (i.e. software) meets the definition of a medical device.
- Are we solely responsible for this integration to demonstrate the safety and effectiveness of our plugin?
It depends on the level of collaboration with the PACS manufacturer. I think it ought to be a shared responsibility. You cannot really do such a validation without their support.

- Should we demonstrate that we do not impact safety and effectiveness of the PACS?
yes (with their collaboration)

- Should we contact the PACS to perform a kind of qualification/validation?
yes, after all its their system. They know staff about that PACS that you don't know and you know staff about your plugin that they don't know. You'll need to collaborate for effective validation. Hopefully, there is a mutual business benefit.

- Any other things to do?
The IFUs needs to be revised. Also some of the software QA docs. And possibly some regulatory notifications, especially if you or the PACS manufacturer needs to do some software changes to support the integration.

Note that our plugin execute our AI specific algorithm onto the images displayed by the PACS. Of course, the original IFU of the PACS is no more the same but because of our plugin only.
Does anyone have an idea?
The IFUs needs to reflect this change.

Shimon
 
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