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The Testing and Risk Management Impacts of Changing a Medical Device

Thor Rollins  (Director: Toxicology and E&L, Nelson Laboratories, LLC)

Location: 210C

Date: Wednesday, February 12

Time: 3:15 pm - 4:00 pm

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

Vault Recording: TBD

The one constant for medical devices is change. From improved design, new suppliers, better processes, or supplier change notification, we are constantly dealing with the impact of change. In this session we will discuss the possible impact of changes to safety and what is needed to mitigate biocompatibility risks from a change.

Topics covered include:

  • Guidance on which changes would be considered impactful and which ones are low risk
  • What procedures can be put into place to evaluate and deal with changes
  • What information is needed before a change can be evaluated
  • Planning the cheapest and easiest test system to accept the change
  • Implications for your risk management processes

Presentation File