Chicago Chapter Webcast: Practical Tips to Meet Post Market Expectations for EU-MDR and EU-IVDR

2.0
RAC Credits
Monday, 03 May 2021 (11:30 AM) - Monday, 03 May 2021 (1:30 PM) Central Time (US & Canada)

Member: $10
Nonmember: $25

Description

Are you ready?  New requirements for Post Market Surveillance have significantly raised the bar for manufacturers, and the new requirements for Post Market Surveillance are right around the corner.  

Continuous evaluation and improvement of devices is at the very heart of this change. The Regulations introduce requirements for active collection and analysis of postmarket experiences for legacy devices as well as new products, effective on the date of application for each regulation (i.e., no soft transition). New processes and governance will be needed to support this assessment and ongoing technical documentation updates for both the MDR and IVDR.

Engage with professionals from the regulatory community for an interactive session where we will discuss what should be in place now and as part of the MDR/IVDR compliant technical documentation, including current interpretations and expectations of the Notified Bodies, Authorized Representatives and Competent Authorities.

Postmarket Surveillance

  • Active data collection
  • Identifying potential input sources
  • Surveillance proportionate to risk and device type
  • Procedure updates
  • Status of guidance and templates

Postmarket Requirements

  • Postmarket Clinical / Performance Follow-up studies (PMCF/PMPF)
  • Continuously monitor state of the art and clinical data
  • Mechanisms to understand benefit-risk estimates, emerging off-label use, etc.
  • Analysis and reporting requirements (PMS Report, PSUR, PMCF/PMPF evaluation reports)
  • Linkage of postmarket data with other technical documents and departments/functions
  • Resource requirements 
  • Triggers and techniques for actions

There will be live Q&A session at the end of 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 session at the end of the presentation. 

Featured Speaker:
Mindy McCann, vice president regulatory compliance, Qserve Group

Thank you to our Platinum Chapter Sponsors: