Determining the Appropriate Sample Size for Post-Market Studies

With the date of application for the MDR approaching fast, many are struggling to design a PMCF plan to pass the scrutiny of Notified Bodies.

Because of the lack of guidance and experience on PMCF, determining design choices of a PMCF study, such as the sample size, can be a challenge. This webinar will highlight:

  • The importance of sample size justification for your PMCF plan
  • What determines a study sample size
  • The basics of calculating an appropriate sample size

Keywords: Appropriate Sample Size, Post-Market Studies


MEDIE 2018 WEB 29344 copy 2

Jón I. Bergsteinsson
Greenlight Guru Clinical



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