The IMDRF has revised its MDSAP audit approach to align with the FDA’s new Quality Management System Regulation, removing references to the former QSR rule
The FDA’s Quality Management System Regulation is now in effect, requiring medical device companies to transition from the legacy QSR rule to a framework aligned
As the FDA prepares to retire its longstanding Quality System Inspection Technique with the rollout of the new Quality Management System Regulation, QSIT creator and
The FDA’s new Quality Management System Regulation, effective Feb. 2, will allow the agency to review a medical device manufacturer’s internal and supplier audit findings
QualityHub regulatory expert Rebecca Fuller will lead key sessions at KENX’s MedTech and GMP University, offering practical guidance on risk management, DHFs, post-market surveillance, and
After acquiring another company, MedTech and pharmaceutical manufacturers should carefully evaluate and harmonize quality management systems by blending the best practices from each to build
Life sciences companies regulated by the FDA and other authorities must conduct audits to ensure compliance, evaluate quality systems, and mitigate risks to product safety
The EU MDR requires manufacturers to develop and maintain comprehensive technical files that demonstrate a medical device’s compliance with safety, performance, and post-market surveillance requirements.
A leading medical device manufacturer faced costly penalties from an unresolved FDA consent decree due to unaddressed product issues across 50 failure modes. QualityHub’s comprehensive
A global biotechnology leader partnered with QualityHub to conduct thorough third-party audits across its facilities, suppliers, and R&D sites, ensuring rigorous compliance and risk management.