FDA Harmonises Quality System Regulations with ISO 13485: Implications and Challenges for Medical Device Manufacturers
The FDA’s harmonisation of its Quality System Regulation (QSR) with ISO 13485:2016 is a significant step towards global regulatory alignment, but it also introduces additional requirements that medical device manufacturers must carefully implement to ensure compliance. Additional FDA Requirements over ISO 13485 Document Controls: The FDA's QMSR includes stringent document...