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 ...
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 Issues Guidance on AI for Medical Devices

The Food and Drug Administration (FDA) issued final guidance Monday that explains how medical device manufacturers can use a Predetermined Change Control Plan (PCCP) to update AI-enabled device ...
Forbes

Why Cell And Gene Therapy Design Processes Need More Efficient Quality Controls

Every year, the media informs us that we’re on the cusp of the golden age of something. While the expected trend often comes to fruition, it’s rarely as smooth a process as advertised. Drug discovery ...