We are living in a world that is constantly changing and using forms of media such as videos and live recordings as forms of communication, notification, training and archiving of special events. In this age, we are constantly bombarded with Tweets, G-Chats and Facebook posts that have videos attached. We can stream tv shows, live news reporting and sports events in real time.
On June 11, 2019, the FDA held a CDRH webinar on the Q-Submission Program for Medical Device Submissions. The webinar was based on the recent May 7, 2019 Final Guidance document titled “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program.” This guidance document supersedes “Requests for Feedback on Medical Device Submissions: Pre-Submission Program and Meetings with FDA and Staff.”
I am currently attending the SDMD (Software Design for Medical Devices) Global IQPC conference in Berlin, where I presented on “Harmonization of Agile Methodology and Medical Device Design Control”. This topic was chosen because, currently, there is no FDA Guidance on this issue, and to provide insight to developers to implement these systems using a lean,