Software Validation for Medical Devices – FAQs

Over the years, we have collected a lot of software validation questions, and we are using it to create a frequently asked questions blog posting. I thought our YouTube subscribers might be interested in hearing the most common questions and the answers to those software validation questions. If you have any questions that you would like to answer live, please join us and type in your questions. OTS 2023 Guidance ➤ https://www.fda.gov/regulatory-information/search-fda-guidance-documents/shelf-software-use-medical-devices 2023 Guidance ➤ https://www.fda.gov/regulatory-information/search-fda-guidance-documents/content-premarket-submissions-device-software-functions AI 2023 Guidance ➤ https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial Clinical Decision Support 2022 Guidance ➤ https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-decision-support-software Mobile App 2022 Guidance ➤ https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-device-software-functions-and-mobile-medical-applications 2002 Guidance ➤ https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-principles-software-validation