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Explore the Convergence of Global Regulatory Trends Impacting Quality Management Systems (QMS): Risk Management, Clinical Evaluations, and Post Market Surveillance

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

Location: 210D

Date: Wednesday, February 12

Time: 9:45 am - 10:30 am

Track: MD&M Conference: Understanding the Impact of Recent Changes to Quality Standards (in partnership with AAMI)

Vault Recording: TBD

The new and changed requirements for a risk management system according to the third edition ISO 14971:2019 and Regulation (EU) 2017/745 on medical devices will influence the technical documentation through the medical device lifecycle and through a manufactures QMS.

Topics covered include:

  • Effects of Clinical evaluation requirements according to the Regulation (EU) 2017/745 and the MEDDEV 2.7/1 rev. 4 which is a substantial part of the technical documentation, has significant influence on the QMS as well as approval and certification
  • How to incorporate the changes in ISO 14971:2019 and your compliant ISO 13485:2016 QMS
  • How to comply with ISO 13485:2016 specific requirement for Post Market Surveillance (PMS) as well as several new PMS requirements found in Regulation (EU) 2017/745
  • Understand the correlation between risk management, clinical evaluation and other post market surveillance activities to ensure the necessary linkages and reference needed in multiple QMS procedures in order to comply with new Global Regulatory expectations

Presentation File