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)

FDA’s AI Device Regulations: Key Updates & Compliance Strategies for Medtech Success

In the past 18 months, the FDA has outlined clear guidelines for designing, documenting, updating, and monitoring AI-powered ...
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 ...
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”, ...
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 ...
PharmTech

Engineering Advanced Pharmaceutical Processes: Design, Control, and Risk Reduction

This article explores key engineering strategies that support this transformation, including hybrid reactor design, clean-in-place optimization, automation architecture, and modular scalability.