Dear Chandu, Ginger and Michael,
thank you for your feedback.
In fact the PC is not really a commercially available PC, but a custom assembled PC platform. And we supply this general purpose computing device with our composition SW installed on it. So indeed it falls under a manufacturer supplied system.
According the MEDDEV, our reasoning was:
The device is derived from a general-purpose computer holding no medical certifications.
"Products with a multiple purpose which may be used occasionally in a medical environment are normally not medical devices, unless a specific medical intended purpose is assigned to them" (MEDDEV 2.1/1).
As we do not ascribe a specific medical purpose to the PC itself we believe it cannot be a medical device.
Also, the PC hardware only complies with the standard for IT equipment IEC 60950 but.does not comply with the EN 60601 and EN 60601-1-2 (EMC). We do not know how we can treat the whole system as a medical device without making the PC compliant with the 60601 (without hardware changes).
That's why we separated the PC and the composition SW. However we considered the SW to but embedded SW as it is factory installed and not stand-alone SW . For
Europe we do not consider the system as a medical device and we did not think we have to apply CE mark for the composition SW because it is embedded. But we do apply risk management.
For the FDA we document the SW as moderate level of concern.
So main question is, how do we have to treat the computer as part of the medical device, especially regarding the fact it has no medical certifications (IEC 60601)?
All inputs for a pragmatic approach are very welcome.
Many thanks
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Eric Caus
Barco Nv
Kortrijk
Belgium
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Original Message:
Sent: 21-Nov-2017 07:31
From: Chandu Patil
Subject: general purpose PC with factory installed SW with medical purpose
Hi Eric,
I have seen two ends of this scenario, based on whether the manufacturer supplies the general purpose computing device or not. In case the manufacturer does not, the specifications for the computing platform is stated. It is also generally the case that any hardware used in external. Off course this may be acceptable to the FDA, but results in quite a lot of work for post market activity to ensure that the customer is using the right platform.
For manufacturer supplied system, the whole system is considered a medical device. This is particularly true if there is additional internal hardware and if it incorporates embedded software. Looks like your system falls in this category. You must then include the OTS software and hardware in your risk analysis, treat it as such and control its configuration.
Hope that is helpful.
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Chandu Patil
United Kingdom
Original Message:
Sent: 20-Nov-2017 03:22
From: Eric Caus
Subject: general purpose PC with factory installed SW with medical purpose
Dear Community members,
I have a question about how to handle a general purpose computer where we add some of our own boards (e.g. graphic board, which are also not medical devices) and load compositor software on it. We treat this composition SW as medical device by performing ISO 14971 risk management, document it as Moderate level of concern for FDA etc.
So the complete device is a computer-alike IT product, certified to IEC 60950 with windows 7 embedded operating system (automated Windows update process has been disabled). It is brought on the market with factory-installed composition software with medical device functionality (composing surgical video images).
How would you categorize this product? Is the complete product a medical device because of the software functionality? Yet, the (PC) device is not certified to the medical harmonized standards. Or is the software a medical device on its own? Yet, it is embedded, and hence is not a standalone software.
We would appreciate some good ideas how to approach this case.
Many thanks!
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Eric Caus
Barco Nv
Kortrijk
Belgium
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