QSR Archives - QualityHub

QHub Insights║The Evolution of Medical Device Industry Training Requirements

February 24, 2026

With the introduction of its new Quality Management System Regulation (QMSR), the FDA has transitioned MedTech personnel requirements from QSR Sec. 820.25 to ISO 13485

QHub Insights║Successful MedTechs Use Management Controls to Oversee Quality Systems, Avoid FDA Risk. Here’s How Yours Can, Too

December 4, 2025

Effective management control is essential for medical device companies, as FDA views executive leadership as ultimately responsible for quality system performance and many deficiencies stem

QHub Insights║20 Years On, Outcome of FDA v. Utah Medical Still Reverberates, Say Investigator, Lawyer Involved In 2005 QSR Case

October 29, 2025

Former FDA investigator Lori Carr and Alson & Bird litigation attorney Dan Jarcho share their memories of US v. Utah Medical Products, a landmark GMP