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Welcome to the ATX West 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.

Better Practices for Product Life-Cycle Risk Management

Janet Michener Whipple  (Partner, Med Device & IVD, Validant)

Location: 210C

Date: Wednesday, February 12

Time: 4:05 pm - 5:00 pm

Track: MD&M Conference: Materials, Testing & Risk Management Solutions

Vault Recording: TBD

Is your product risk management file collecting dust? This session will discuss better practices in utilizing risk management throughout the product life cycle from concept through end of product life. It will show how risk management links from design and manufacturing to post-market surveillance to ensure product safety and to support risk-based decisions. Use of risk management can reduce cost while improving quality and delivery cycle time. Bring your risk management file to life and reap the benefits.

Topics covered include:

  • Understand how the risk management file can be used throughout the product life-cycle
  • Discuss how risk management can reduce cost
  • An interactive example of how risk management links to design V&V, labeling, complaints, and post-market surveillance for a fictional medical device
  • Tips for improving your risk management file to support a data-driven risk-based approach to quality

Presentation File