• Feature ArticlesFeature Articles

    Getting ready for the FDA’s upcoming QMSR

    The FDA’s Quality Management System Regulation (QMSR) proposal, paired with the International Organization for Standardization’s ISO 13485:2016, is expected to deliver cost savings to medtech organizations that adhere to both requirements. This article covers the differences between QMSR, ISO 13485:2016, and the Medical Device Single Audit Program (MDSAP) so leaders can prepare for the upcoming changes.    Keywords – MDSAP, quality management, quality system regulat...
  • Regulatory NewsRegulatory News

    FDA officials discuss prioritizing inspections, QMSR transition

    Officials from the US Food and Drug Administration (FDA) explained how the agency is prioritizing medical device inspections as it resumes normalized operations. They also announced a new “careful and cautious” approach to conducting foreign inspections.   At the 4 May virtual MedCon Conference which was hosted by the Association of Food and Drug Officials (AFDO) and the Regulatory Affairs Professionals Society (RAPS), officials also addressed how it will balance the u...