Dear Nadine,
In case you are making your software available for use by the surgeon, yes, it should be considered a medical device. It does not matter whether the surgeon pays for its use, or whether he can use the software for free.
Other than that, I would agree with the response by Anonymous, that it depends on how you use your software. There is a difference between a generic planning software and a software used for planning a specific patient-matched implant.
Let me know if you need any additional help, we can take this further offline if you wish.
Good luck!
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Mieke Janssen
Sr. Regulatory Expert Medical Devices
Maaseik
Belgium
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Original Message:
Sent: 01-Mar-2021 16:08
From: Nadine Adia
Subject: Software used by surgeon for planning a patient match implant
Dear peers,
I'm wondering how could I classify a software which is used by a surgeon for planning a design and manufacturing a patient match implant. This software will be use only for planning and based on this information an other software will take the flow for designing en manufacturing.
Is it a medical device , how could I proceed for regulatory compliance please?
Thank you in advance for your advice.
Rgds,
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Nadine Adia
Quebec QC
Canada
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