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Ensuring your Quality Management System is Ready for the New EU MDR Beyond the Requirements of ISO 13485:2016

Kim Trautman (Executive Vice President, Medical Device International Services, NSF International)

Location: 210D

Date: Wednesday, February 6

Time: 11:00am - 11:45am

Track: MD&M West: Regulatory & Quality Update

Vault Recording: TBD

Many times, due to mergers, acquisitions, or other reasons, manufacturers have more than one QMS. However, under the new EU MDR, there are requirements for the QMS to be placed where the regulatory requirements join to be implemented systemically throughout the life cycle of the device. Under the new regulatory environment, manufacturers will be required to upgrade their quality systems, which can lead to significant investments and increased senior management involvement.

Topics covered include:
  • Key obligations for a Quality Management System meeting regulatory requirements under the new EU MDR
  • What you need to know to be prepared for the 2020 transition period
  • Points to consider to help plan for updates to your own QMS to ensure compliance