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 ...
Yahoo Finance

US FDA Medical Device Quality System (QSR) Compliance Course: Design Controls, Verification ...

Dublin, Sept. 22, 2025 (GLOBE NEWSWIRE) -- The "US FDA Medical Device Quality System (QSR) Compliance: Design Controls, Verification & Validation (Oct 27th - Oct 28th, 2025)" training has been added ...
Yahoo Finance

2 Day Medical Device QMS Optimizing Design Controls and Validation Training Course: Boost ...

Dublin, Sept. 23, 2025 (GLOBE NEWSWIRE) -- The "Bottlenecks to Flow: Optimizing Design Controls and Validation in Medical Device QMS (Oct 23rd - Oct 24th, 2025)" training has been added to ...
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 ...