RAPS

Experts: Strong design controls are key to FDA device approval

LINTHICUM HEIGHTS, MD – Sponsors interested in getting their medical device applications approved by the US Food and Drug Administration (FDA) should have robust design controls in place to ensure ...
Medical Device and Diagnostic Industry (MD+DI)

From Silos to Integration: FDA’s Framework for Digital & Intelligent Devices

Finally, the terminology shift worth flagging is QMSR replacing the “Design History File” with “Design and Development File”, ...
RAPS

Updated: FDA Flags Lack of Design Controls at Mibo Medical Group

The US Food and Drug Administration (FDA) last November sent a letter to Texas-based Mibo Medical Group to say that the firm addressed the violations in a warning letter from December 2018. "Future ...
JD Supra

FDA updates compliance program inspection manual for the QMSR age

On February 2, 2026, the U.S. Food and Drug Administration (FDA) published its anticipated compliance program manual, Inspection of Medical Device Manufacturers (CP 7382.850), to explain how the ...