REGISTRATION CLOSED- Indiana Chapter: Lunch and Learn Webcast: Implementing Risk-Based Decision Maki

When:  Apr 16, 2020 from 12:00 PM to 1:00 PM (ET)

Member: $20 
Nonmember: $30

Eat your lunch and join the RAPS Indiana Chapter online to review the recent edition of ISO 13485 Medical Devices quality management systems requirements for regulatory purposes, which introduces the concept of a risk-based approach to decision making. Companies are struggling with implementation of this risk-based approach throughout the entire product lifecycle because there is no definition of how it is to be done. Some companies are using the contents of risk management files developed as a result of compliance with ISO 14971 Medical Devices and may not be providing adequate safety and effectiveness reviews of postmarket surveillance data.

ISO 13485 provides guidelines for using risk-based decision making within quality management systems, but medical device and in vitro diagnostics manufacturers may struggle with how to implement a process that also will be supported by regulatory agencies such as the US Food and Drug Administration (FDA) or notified bodies in the EU. This session will discuss strategic approaches to using the risk management file developed from implementation of ISO 14971:2012 for product related risk-based decision making. Upon completion of this webcast, participants should be able to:

  • Identify processes within the QMS where product risk-based decision making can be done.
  • Know how to utilize the RMF contents to assist in the risk-based decision making.
  • Know how to assess postmarket surveillance data for safety and effectiveness relative to the harms and hazards listed in the RMF.

This event is brought to you by the RAPS Indiana Chapter to encourage knowledge sharing and community development. RAC holders may claim one RAC recertification credit. All registrants will have access to the presentation slides and the on-demand recording for one year.

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 48 hours prior to the start of the webcast. A live Q&A portion with the speaker(s) will follow the presentation.

Featured Speaker:
Tiea Theurer, lead auditor, NSAI