This presentation provides an overview of the Quality Management System Regulation, including preamble and final rule, a review of some important definitions and their hierarchy of application, and a ...

In the changing field of technology, progress is driven by the pursuit of innovation which plays a vital role in enhancing patient care, prolonging lives, and improving overall healthcare outcomes.

Is your medical device company ready for the QMSR shift? Engineer Aldo Vidinha explains why "checkbox compliance" is over and how the FDA’s alignment with ISO 13485 redefines quality as a connected, ...

Fulfilling the required changes to FDA’s quality management system regulation (QMSR) ahead of February 2026’s compliance deadline is much ado about nothing for most companies, according to Kim ...

The medical device industry has been anticipating harmonziation between FDA's quality regulation requirements and the international consensus standard for medical device quality for years. Now, it ...