Regulatory sequencing clinic for device teams

Device translation fails for administrative reasons far more often than scientific ones, and almost all of those reasons come down to sequencing. Nearly everything a device company must eventually produce is straightforward if begun at the right moment and ruinous if begun late.

This session lays out the sequence: when to open the risk file, when the quality system needs to be operating rather than drafted, when usability work is cheap and when it becomes a change request, and how long governance approvals actually take as opposed to how long project plans assume.

It is deliberately not a training course. It is ninety minutes intended to reorder your development plan, delivered by someone who spent eleven years assessing submissions and has watched the same avoidable failures several hundred times.

There is a segment on software as a medical device, where development teams accustomed to continuous deployment meet a framework expecting a defined intended use and controlled change. Both positions are reasonable and reconciling them is work.