The blog related to this video is found on our website: medicaldeviceacademy.com/software-as-a-medical-device/ The following six (6) FDA guidance documents are referenced in the video: 1. General Principles of Software Validation (2002) - www.fda.gov/regulatory-information/search-fda-guidance-documents/general-principles-software-validation 2. Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (2005) - www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-content-premarket-submissions-software-contained-medical-devices 3. Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (2014) - 4. Postmarket Management of Cybersecurity in Medical Devices (2016) - www.fda.gov/regulatory-information/search-fda-guidance-documents/postmarket-management-cybersecurity-medical-devices 5. Off-The-Shelf Software Use in Medical Devices (2019) - www.fda.gov/regulatory-information/search-fda-guidance-documents/shelf-software-use-medical-devices 6. Deciding When to Submit a 510(k) for a Software Change to an Existing Device - www.fda.gov/media/99785/download
Excellent and absolutely clear inputs Rob! Thanks a lot 👍
You are very welcome
The blog related to this video is found on our website: medicaldeviceacademy.com/software-as-a-medical-device/
The following six (6) FDA guidance documents are referenced in the video:
1. General Principles of Software Validation (2002) - www.fda.gov/regulatory-information/search-fda-guidance-documents/general-principles-software-validation
2. Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (2005) - www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-content-premarket-submissions-software-contained-medical-devices
3. Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (2014) -
4. Postmarket Management of Cybersecurity in Medical Devices (2016) - www.fda.gov/regulatory-information/search-fda-guidance-documents/postmarket-management-cybersecurity-medical-devices
5. Off-The-Shelf Software Use in Medical Devices (2019) - www.fda.gov/regulatory-information/search-fda-guidance-documents/shelf-software-use-medical-devices
6. Deciding When to Submit a 510(k) for a Software Change to an Existing Device - www.fda.gov/media/99785/download