Statistical Analysis for Heart Monitors

#1
Hi everyone,

I am an English person who's never taken statistics (yikes, right?). Well, now I'm working a job where I need some ideas of what kinds of statistical analysis might be used to make sure that medical devices (heart monitors in this case) are working properly.

I'm writing a standard operating procedure that's intended to meet the requirements from this section of FDA law:

"(a) Where appropriate, each manufacturer shall establish and maintain procedures for identifying valid statistical techniques required for establishing, controlling, and verifying the acceptability of process capability and production characteristics."

Do you have any suggestions of the kinds of statistical techniques that might be used to meet these requirements?

Thank you!