raqaphantom
Registered
Hello. Question regarding the issuing of a Declaration of Conformity with regards to project/development timelines.
Background: a Class IIb software-as-medical-device under MDR.
The most recent release of the software addresses bugs, patches, improvement based on customer feedback, incorporated since the initial cleared device; it was determined that the changes are not significant.
The final software release version number, which comprises part of the device identification, has been determined. The device has completed verification and validation testing, but has not gone through final design transfer stages (ie, assessment that Device Master Record is complete, risk management documentation is drafted but not finalized, etc).
Can a Declaration of Conformity for the to-be-released version be created? Or is it best to wait until official release of all finalized associated documentation?
I'm leaning towards saying that all documentation needs to be completed prior to the DoC being issued, but looking for some guidance either way.
Background: a Class IIb software-as-medical-device under MDR.
The most recent release of the software addresses bugs, patches, improvement based on customer feedback, incorporated since the initial cleared device; it was determined that the changes are not significant.
The final software release version number, which comprises part of the device identification, has been determined. The device has completed verification and validation testing, but has not gone through final design transfer stages (ie, assessment that Device Master Record is complete, risk management documentation is drafted but not finalized, etc).
Can a Declaration of Conformity for the to-be-released version be created? Or is it best to wait until official release of all finalized associated documentation?
I'm leaning towards saying that all documentation needs to be completed prior to the DoC being issued, but looking for some guidance either way.
