Risk & Hazard Analysis?
Risk & Hazard Analysis?
Does anyone else here document device or software that has FDA clearance? If so, have you done an Off the Shelf Software Validation document with a risk and hazard analysis of Flare? I've been told by my Quality/Regulatory department I'll need to do one, barring an existing Certificate of Compliance from Madcap. Searching for others who can offer tips and such.
The things that we plan and measure are the things that get done.