News & Analysis

MedTech’s QMSR: FDA Says Live Training In Store For Investigators This Summer

May 1, 2025

The FDA is preparing for its new Quality Management System Regulation by training investigators on a new inspection model replacing the old QSIT method. This

‘Tip of the Iceberg’: Data Integrity a Front-and-Center Concern for FDA, QHub Expert Says

May 1, 2025

The FDA has uncovered widespread data integrity issues in medical device submissions, particularly from third-party labs, including two in China. As a result, the agency

FDA to MedTech Companies Waiting to Comply With New QMSR Rule: ‘Don’t Do That’

April 24, 2025

The FDA urges medical device makers to prepare now for the new Quality Management System Regulation. Though similar to ISO 13485, compliance requires active effort.