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Better Practices for Product Life-Cycle Risk Management

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

Location: 210C

Date: Wednesday, February 12

Time: 4:05pm - 5:00pm

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

ANA2020__BetterPracticesProductLifeCycleRisk_Whipple.pdf