Part 1 of 2: This Insights piece makes the case that FDA inspection readiness starts with deliberately structuring a small, well-rehearsed “front-room” team – typically
Who you put in the “front room” can make or break an FDA inspection. QualityHub’s Anne Albertz explains why the best host isn’t your top
Jennifer Maandi’s lifelong interest in language has shaped a career in medical device quality, where communication, interpretation, and attention to detail are essential. Now joining
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
Mock audits should do more than verify compliance. QualityHub experts say manufacturers should use realistic, risk-based practice inspections that mirror the FDA’s investigative approach, prepare
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