B
brentg
Hi All
I have been pruning info from this forum for some time now and am finally making the first post to see if any of you can help me out.
We are a Class IIa Medical Device have been CE & FDA certified since 2013 plus we are ISO 9001 and 13485 certified.
Our device is for providing oscillations the chest to product mucus in brief.
We do have 2 firmwares on the device one for display purposes the other to control. Since the conception we have classified ourselves as class A software for both.
Only in our very latest audit has this been brought into question and after lengthy further risk analysis still has one blocking point.
auditor argues that if the device failed to stop then the therapy would continue. My risk response of the microprocessor would stop the blower operating therefore cutting therapy was refused stating that a secondary hardware watchdog can only be used to mitigate that risk.
The acceptance of the Class A and our fully completed 62304 checklist has been fine for 5 previous audits yet trying to explain to this current auditor that our device wouldnt cause problems even if the therapy continued well past 20 minutes into 5 hours plus as it is extremely low background pressure andis more massage like is falling on deaf ears.
Any advice out there for my predicament other than buckle and go class B or C and increase the regulatory paperwork yet again
Many thanks
Brent
I have been pruning info from this forum for some time now and am finally making the first post to see if any of you can help me out.
We are a Class IIa Medical Device have been CE & FDA certified since 2013 plus we are ISO 9001 and 13485 certified.
Our device is for providing oscillations the chest to product mucus in brief.
We do have 2 firmwares on the device one for display purposes the other to control. Since the conception we have classified ourselves as class A software for both.
Only in our very latest audit has this been brought into question and after lengthy further risk analysis still has one blocking point.
auditor argues that if the device failed to stop then the therapy would continue. My risk response of the microprocessor would stop the blower operating therefore cutting therapy was refused stating that a secondary hardware watchdog can only be used to mitigate that risk.
The acceptance of the Class A and our fully completed 62304 checklist has been fine for 5 previous audits yet trying to explain to this current auditor that our device wouldnt cause problems even if the therapy continued well past 20 minutes into 5 hours plus as it is extremely low background pressure andis more massage like is falling on deaf ears.
Any advice out there for my predicament other than buckle and go class B or C and increase the regulatory paperwork yet again
Many thanks
Brent