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

Speakers

Jón I. Bergsteinsson Greenlight Guru Clinical