C
CerysC
Hi
I was wondering if anyone can help me with the following question.
For medical device software that was in place on the market before the revision to European Medical Device Directive (MDD 2007/47/EC), what regulations should the medical device software have been following before this ?
My question is what do companies do for Legacy systems that have been in place in the last 10 years on the market ?
Do all companies have to revalidate their medical online software systems in accordance with the medical device directive that state that standalone software is now seen as an active medical device ?
The medical software we produce takes readings from a hardware device and produces a report from these readings that can be used for diagnosis.
Any advice or comments are greatly appreciated !!
I was wondering if anyone can help me with the following question.
For medical device software that was in place on the market before the revision to European Medical Device Directive (MDD 2007/47/EC), what regulations should the medical device software have been following before this ?
My question is what do companies do for Legacy systems that have been in place in the last 10 years on the market ?
Do all companies have to revalidate their medical online software systems in accordance with the medical device directive that state that standalone software is now seen as an active medical device ?
The medical software we produce takes readings from a hardware device and produces a report from these readings that can be used for diagnosis.
Any advice or comments are greatly appreciated !!
