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June 14, 2017

Key Factors that Determine a Successful Reusable Medical Device Cleaning Validation

There are many considerations that need to be taken into account by medical device manufacturers when designing reprocessing validations, and it only takes one oversight to cause a failure mode. Alpa Patel, Senior Scientist at Nelson Laboratories and member of AAMI, ASTM, and AATB, will share her expertise in this presentation and discuss the key factors that determine a successful reusable medical device cleaning validation. Participants who attend the presentation will learn:

  • The key factors that determine a successful cleaning validation
  • The current thinking of FDA regarding cleaning validations
  • The main documents relevant to cleaning validations
  • The stages cleaning validations should be considered when designing a reusable medical device
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