If it sends data of a non-medical nature, it won't in principle even be a health software.
Do you have any need to use 82304-1? If not, I would not bother, and would control everything under 62304 if the case.
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Marcelo Antunes
Regulatory Strategy Consultant
São Paulo
Brazil
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Original Message:
Sent: 17-Jul-2018 07:52
From: Mike Kilkelly
Subject: IEC 82304 - Health software
Hello Marcelo,
Thank you so much for your reply. The App is used to control the device primarily, but also sends data to and from the user (of a non-medical nature) to motivate them to use the device and as a marketing tool. Does this have any impact on the applicability of IEC 82304?
regards
Mike
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Mike Kilkelly
Quality Manager
Galway
Ireland
Original Message:
Sent: 17-Jul-2018 07:08
From: Marcelo Antunes
Subject: IEC 82304 - Health software
If the app is to control the device (and only does this), it would be outside IEC 82304-1.
IEC 82304-1 is the product standard for standalone software (including Software as Medical Device). IN the case of your device, the "product safety" standard is IEC 60601.
Scope of 82304-1is:
This Part of 82304 applies to the SAFETY and SECURITY of HEALTH SOFTWARE PRODUCTS designed to operate on general computing platforms and intended to be placed on the market without dedicated hardware, and its primary focus is on the requirements for MANUFACTURERS.
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Marcelo Antunes
Regulatory Strategy Consultant
São Paulo
Brazil
Original Message:
Sent: 17-Jul-2018 05:52
From: Mike Kilkelly
Subject: IEC 82304 - Health software
Hi
I would be very grateful for any help with this query regarding the applicability of IEC 82304 to one of our products i.e. an Electrical Muscle Stimulator that incorporates an App (Android and iOS).
The product is FDA cleared as a Class II device and our software development complies with IEC 62304.
My question is as to whether IEC 82304 is applicable to this product or similar future products.
One reading of the standard suggests that our App is "software as part of a medical device" and is outside the scope of IEC 82304.
However as the device is being controlled by an a standalone App on a mobile device it may bring us into the scope of IEC 82304.
Any help with this is very welcome.
regards
Mike
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Mike Kilkelly
Quality Manager
Galway
Ireland
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