If our Essential Requirements states we tested to a certain standard xyz:2010 and passed in our original device approval and we are making a substantial change to the device, if the standard was updated to xyz2020 in the interim Do we:
1) list compliance with the xyz2010 standard?
2) Have to perform new testing to the xyzx2020 standard?
3) when new versions of the standard are updated how does that impact our testing requirements?
1) list compliance with the xyz2010 standard?
2) Have to perform new testing to the xyzx2020 standard?
3) when new versions of the standard are updated how does that impact our testing requirements?