Ginger Glaser brings up a great point. If software is used in surgeries to design/plan for creating custom devices or surgical approaches/treatment planning, then it is usually regulated as medical device. (Look under Procode LLZ for examples).
With practice of medicine, a doctor may develop and use their own software and may use even within their limited associated practice (is treated with enforcement discretion). But once it gets sold to others and used more widely, it becomes regulated and enforced.
Intended use/risk management will then drive Level of Concern/Safety Class analysis and required software D&D per IEC 62304.
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Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com------------------------------
Original Message:
Sent: 20-Jul-2020 09:55
From: Ginger Glaser
Subject: SOFTWARE AS A MEDICAL DEVICE
As a note though, the exact nature of this design tool matters. For instance, software used by a medical device company to design implants would not meet the definition of a device. However, software sold to a hospital (or surgeon) for use in designing custom implants most likely would be considered a medical device [note: even if it is the same software].
Thus, I'd encourage you to write a thorough description of the software and its intended use (including site of use, intended users etc) and compare it to the definition of a medical device. As others have noted, if it is not a medical device, it could very well be software being used in your QS and thus should be validated appropriately.
g-
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Ginger Glaser RAC
Chief Technology Officer
MN
Original Message:
Sent: 18-Jul-2020 21:30
From: HEMANG KOTECHA
Subject: SOFTWARE AS A MEDICAL DEVICE
Hi Nadine,
Based on the (limited) information that you have provided, it seems that this software used to design specific implant is not a medical device (i.e. not a SaMD), based on the definition of SaMD per IMDRF. However, you will need this software to be validated for audit purposes.
Refer to IMDRF guidance, FDA guidance, Health Canada Guidance on SaMD.
Also refer to this article in link below:
https://orthogonal.io/insights/software-as-a-medical-device-samd-basics/
Hope this helps.
Best,
Hemang.
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HEMANG KOTECHA
Wayne NJ
United States
Original Message:
Sent: 17-Jul-2020 13:55
From: Nadine Adia
Subject: SOFTWARE AS A MEDICAL DEVICE
Dear all,
I need your advise please.
I'm wondering in which case the software should be considered as a medical device for US , Canada, Europe.
For example a software used internally to design a specific implant, can I say that it also a device?
Thank you in advance for your help.
Rgds,
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Nadine Adia
Quebec QC
Canada
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