Software Validation Documentation for FDA 510(k) pre-market notification submission

[@pabloj.gutierrez8674]

Hello! This is a very informative presentation... Thanks for sharing! Would you consider sharing a webinar for non-medical device software? I mean, software that medical device companies use to support their QMSs... Like CAPA, Audit, and, Training Systems. And also production software related? Lastly, please also talk about the verification and validation of spreadsheets... Thanks and best regards...

[@MedicalDeviceAcademy]

That's a good suggestion. We have a procedure for quality system software (i.e. Software Tool Validation, SYS-051), and there is a standard for this: ISO/TR 80002-2:2017 - www.iso.org/standard/60044.html. I'm sure we will eventually get around to doing a training webinar on this, but I don't have a timeline for you. If we get some additional comments asking for this, I will definitely prioritize the webinar suggestion.