Ann: ResApp Clears Major Milestone for CE and TGA with ISO 13485, page-46

A few questions from an alternate angle that if someone could shed light on would be great.

With ISO official cert imminent and FDA looking to use as their standard, could there be a risk that as the trials were conducted whilst not certified and ISO compliance wouldn’t be recognised w.r.t trial data? Or given the algo is the same when approval received we are good to go.

I also thought ISO was for the quality control of the device/software manufacture and didn’t automatically equate to validation the algorithm itself was accurate/correct? Kinda sounds like people are taking this and using it to positively spin US results, which as we know were less than Aus. Would be nice to hear in layman’s terms.

GL!