JD Supra

Quality Culture Under QMSR: What FDA Really Wants—and How Leaders Can Deliver

When the U.S. Food and Drug Administration (FDA) finalized the Quality Management System Regulation (QMSR), it did more than modernize 21 CFR Part 820. The preamble explains that the rule primarily ...
JD Supra

FDA Signals Major Shift for QMSR Transition for Medical Device Applications

Brendan Carroll, Jessica Ritsick, Jong Ho "Philip" Won, Ph.D. Our FDA: Drug & Device Team provides recommendations based on Food & Drug Administration (FDA) draft guidance on Quality Management System ...
Business Wire

Pharmaceutical, Diagnostic, and Biologics Product, Equipment/Process, Software and QMS Verification and Validation Training Course - ResearchAndMarkets.com

DUBLIN--(BUSINESS WIRE)--The "Verification and Validation - Product, Equipment/Process, Software and QMS" training has been added to ResearchAndMarkets.com's offering. This seminar will provide ...
MD&M East

Embrace FDA Regulations: Turn Medtech Compliance Into Your Competitive Edge

Many Medtech startups view FDA and similar regulatory bodies as a roadblock. Something that is there to get in their way, slow them down, and cost them a fortune. Smart companies see regulations as an ...
BioWorld

FDA: proper ‘attitude’ now a requirement under device regs

The U.S. FDA’s Jan. 14 webinar for the new Quality Management System Regulation included some fairly predictable content, but one member of the FDA staff mentioned that the agency now expects ...