Hi all,
We are CE marked for a class IIa medical device. It's an aid in diagnosis for adult. We would like to extend the intended use to children.
The SW will have to be modified to fit with the new intended use.
We would like to be able to continue to update the App while the NB reviews the technical file and gives us their approval for this substantial change. Since it may take some times. I doubt they will have to do it before may 2020, but management asks me to try.
I was wondering if the following strategy would be OK or if you have a better suggestion.
Current SW: V1.2.0
Tech File send to NB for extension to children : SW V1.3.0, (will never be placed on the market).
NB reviews the Tech File
Update of SW : V1.3.1 (placed on the market)
Update of SW: V1.4.0 (placed on the market)
I think I will apply the same strategy for IFU versioning.
Thanks for your advices.
We are CE marked for a class IIa medical device. It's an aid in diagnosis for adult. We would like to extend the intended use to children.
The SW will have to be modified to fit with the new intended use.
We would like to be able to continue to update the App while the NB reviews the technical file and gives us their approval for this substantial change. Since it may take some times. I doubt they will have to do it before may 2020, but management asks me to try.
I was wondering if the following strategy would be OK or if you have a better suggestion.
Current SW: V1.2.0
Tech File send to NB for extension to children : SW V1.3.0, (will never be placed on the market).
NB reviews the Tech File
Update of SW : V1.3.1 (placed on the market)
- removal of children feature
- other updates
Update of SW: V1.4.0 (placed on the market)
- add children feature
- other updates
I think I will apply the same strategy for IFU versioning.
Thanks for your advices.