On 31st January 2024, the United States Food and Drug Administrator [USFDA] published an update where the QSR - Quality System Regulation requiring CGMP will be replaced by QMSR - Quality Management System Regulation which harmonises with the global footstep.
Under the QMSR, medical device manufacturers will have to transition their quality management systems in a way that they align with the ISO 13485 standard.
The FDA has determined that the requirements in ISO 13485 are, when taken in totality, substantially similar to the requirements of the QS regulation, providing a similar level of assurance in a firm’s quality management system and ability to consistently manufacture devices that are safe and effective and otherwise in compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Connect with Regulatory Experts and Consultants at Med-Di-Dia by sending us an email at mdd@mddltd.com or by filing this webform - med-di-dia.com/contact.php