A
Hello,
I'm helping a MD manufactoring company with SW regulations as part of my thesis project. In the current project, a robotic prosthetic is being developed which uses SW to control the prosthesis based on the users intent (through biosignals).
As it is a small company, we are looking into seperrating the physical device into an implanted part, and then classify the external attachments as MD accessories to reduce the amount of resources we need to spend on getting an FDA approval.
The controlling SW will be embedded into one of these attachments. My question is if there is any special regulations to concider if the sw is inside a MD accessory?
My guess is that the sw would not be affected by this but I wanted to seek confirmation, and these forums have been very good so far
As a side note, the sw itself will be developed in conformance with the IEC 62304 standard and based on the preliminary RA, it will be a Class B sw.
Thank you for your help
I'm helping a MD manufactoring company with SW regulations as part of my thesis project. In the current project, a robotic prosthetic is being developed which uses SW to control the prosthesis based on the users intent (through biosignals).
As it is a small company, we are looking into seperrating the physical device into an implanted part, and then classify the external attachments as MD accessories to reduce the amount of resources we need to spend on getting an FDA approval.
The controlling SW will be embedded into one of these attachments. My question is if there is any special regulations to concider if the sw is inside a MD accessory?
My guess is that the sw would not be affected by this but I wanted to seek confirmation, and these forums have been very good so far
As a side note, the sw itself will be developed in conformance with the IEC 62304 standard and based on the preliminary RA, it will be a Class B sw.
Thank you for your help
