FDA first announced its intention to “harmonize and modernize” the Quality System Regulation (QSR) for medical devices in Spring of 2018. The idea is to modernize the regulatory framework and harmonize the requirements with the newly revised ISO 13485:2016, the international standard for medical device quality management systems.

Well, it’s about time!

Regulatory ComplianceNaveen AgarwalJune 20, 2019risk management, FDA regulation, safety, medical safety, patient safety, quality system regulation, qsrComment