The Quality Management System Regulation (QMSR): Implications for Manufacturers of Medical Devices
Navigating the New Quality Management System Regulation: Insights from Our Latest White Paper We are excited to announce the release of our comprehensive white paper that delves into the FDA’s newly finalized Quality Management System Regulation (QMSR), effective February 2, 2026. This pivotal regulation, which integrates ISO 13485 standards, aims to simplify and harmonize quality […]
Monitor Performance and Verify by Audit
Author: Anne Holland, CEO and Founder Once your quality system is updated for QMSR, the next critical step is ensuring it’s not just compliant on paper, but in practice. Monitoring performance and verifying compliance through audits is how you protect your company from unexpected findings and costly corrective actions. Training is the first line of defense. Your team […]
QA Consulting, Inc. Welcomes Adrienne Schroll!
We’d like to welcome QA Consulting’s new Senior Quality and Microbiology Consultant, Adrienne Schroll! We’re thrilled to introduce Adrienne Schroll, a proven Quality and Regulatory Affairs leader with 17+ years of experience across the medical device, pharmaceutical, and combination product industries. Adrienne has driven quality strategy, regulatory compliance, and QMS implementation across Class I–III devices—including active implantable and sterile […]
