Although designed for software, Agile’s fundamental values are equally relevant to medical devices.
The design history file establishes the baseline for the design and development of a device.
Comply all the time, not just when FDA announces an inspection.
In this fourth and final foray into Subpart C – Design Controls, Dr. D will review the last three subsections; (h) design transfer, (i) design changes, and (j) the design history file (DHF), located within section 820.30. These final three elements of design control are just as important as the previous subsections dissected as part of Devine Guidance.