MedTech manufacturers would be wise to watch how the FDA is using AI, including for inspections, as closely as they manage their own use of
A CAPA is only as defensible as the evidence behind it. QualityHub SVP Rebecca Fuller explains why Verification of Effectiveness planning should begin with the
Manufacturers that can quickly explain how they validated their software can clear that part of an FDA inspection or notified body audit in minutes, Johnson
“Normalization of deviance” happens when a team keeps accepting small departures from requirements because nothing bad has happened yet, and clean audits, healthy metrics and
Implementing a risk-based CAPA approach requires more than adopting a new decision tree, as demonstrated by QualityHub Senior Consultant Aryssa Wernle’s experience implementing MDIC’s “Make
This QualityHub Expert Brief examines how clear, SOPs strengthen quality systems by standardizing processes, supporting employee competence, and providing objective evidence that work is performed
During a July 22 Town Hall webinar, FDA officials said their new human factors guidance applies only to marketing submissions and doesn’t change MedTech manufacturers’
This QualityHub Expert Brief examines the evolution of training requirements for makers of medical devices, highlights key differences between FDA’s former Quality System Regulation (QSR)
This QualityHub Expert White Paper examines the regulatory foundations, operational principles, and implementation practices associated with effective CAPA systems within the medical device industry. Particular
Despite FDA staffing changes, the agency’s medical device review performance remains strong, according to former FDA leader and current QHub Corporate VP Sean Boyd, who