Chicago Chapter Webcast: Risk Management Through the Lifecycle of Medical Devices

2.0
RAC Credits
Monday, 14 June 2021 (11:00 AM) - Monday, 14 June 2021 (1:00 PM) Central Time (US & Canada)

Member: $10
Nonmember: $25

Description

Risk Management and new regulatory expectations impact all medical devices' technical documentation and post-market surveillance files. Medical device manufacturers should pay special attention to language around benefit-risk analysis, evaluation of overall, residual risk, and production and post-production activities. 

Join for an interactive session where you will:

  • Ensure your QMS and RMS procedures and files are in order to comply with new Global Regulatory expectations. 
  • Understand the correlation between risk management and other post-market surveillance activities to ensure the necessary linkages 
  • Explore how IMDRF adverse event and problem codes can tie your post market data to your risk management file and pre-market data
  • Learn how to incorporate the IMDRF terminologies and codes for categorized Adverse Event Reporting (AER) into your risk management process through the life cycle of your medical devices

There will be a live Q&A available throughout the presentation. 

This event is brought to you by the RAPS Chicago chapter to encourage knowledge sharing and community development. RAC holders may claim 2.0 RAC recertification credits.

Learning Level: Intermediate 
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity. 

RAPS membership provides vital information for regulatory professionals and a place for networking and invaluable connections. Now is a great time to explore the many benefits to RAPS membership, including the Member Knowledge Center and our award-winning, private online community, Regulatory Exchange. Find out more about RAPS membership today.

How Do Webcasts Work?
For the best webcast experience, please use the Google Chrome browser. RAPS webcasts are also mobile- and tablet-accessible for your convenience. Registrants will receive instructions on how to log in 24 hours before the start of the webcast. There will be live Q&A available throughout the presentation. 

Featured Speaker:
Kim Trautman, Medical Device, IVD and Combination Product Expert

Thank you to our Platinum Chapter Sponsors: