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FDA QMSR: What do the Proposed Changes Mean for Industry?

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NAMSA and the Regulatory Affairs Professional Society (RAPS) present this webinar to bring awareness to the U.S. Food and Drug Administration’s (FDA) Quality System Regulation (QSR) proposed changes and what these may mean for the medical device industry and MedTech manufacturers as a whole.

During this webinar, NAMSA’s quality experts will review the FDA’s proposed changes to Quality System Regulation (21 CFR part 820) which is now referred to as Quality Management System Regulation (QMSR). Specifically, we will review the history of quality systems, look at the changes to quality regulations and discuss the FDA’s intent to align with the ISO 13485 standard. Speakers will also provide a focused look at what the proposed QMSR changes mean for device manufacturers’ quality systems, including organizations that adhere to the current FDA QSR standard.

Discussion will include:

  • An overview of the proposed QMSR structure: why, what, when?
  • QMSR & ISO 13485 Comparison: a deeper dive to highlight similarities and differences and their impacts to the industry
  • Next steps as an industry

 

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This NAMSA webinar is hosted in partnership with Regulatory Affairs Professionals Society (RAPS), a third-party provider. For information related to RAPS’s privacy policy and utilization of information, please contact RAPS directly.