QMSR Quick Take: Medtech Consultant Steve Silverman

Steve Silverman is a former compliance director for the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH). He’s now head of The Silverman Group, a consultancy for industry.

This is his quick take on the US Food and Drug Administration’s proposed Quality Management System Regulation. The QMSR would replace the agency’s current Quality System Regulation. The QMSR harmonizes the QSR with international quality systems standard ISO 13485:2016