ATX West, MD&M West, Plastec West, West Pack, and Design & Manufacturing West is part of the Informa Markets Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.


Welcome to the Pacific Design & Manufacturing Presentation Store. Here you can view and download conference and/or show floor theater presentations before, during, and after the event. If you’re looking for a presentation from a specific session that you’re unable to find here, note that it’s likely because the presenter has not provided permission for external use or has not yet shared their presentation with us. Please check back after the event for a more complete catalogue of available presentations.

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: 9:45am - 10:30am

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

ANA2020_Explore_the_Convergence_of_Global__Trautman.pdf