Safety study design

[ElectrospinTech]

Hi everybody,
I am planning a clinical trial focussing on safety of a medical device. I am trying to get feel for calculating the sample size yet most information online is for comparison studies. Does anybody have insight into how to calculate the sample size with a certain power & significance?

thanks all!

Marco

 

[Miner]

I recommend posting your question in elsmarqualityforum They have a very active discussion group for medical devices.