Share this postLet's Talk Risk!Quick Tip: Apply the PDCA approach to your clinical evaluation processCopy linkFacebookEmailNotesMoreQuick Tip: Apply the PDCA approach to your clinical evaluation processClinical evaluation is a key element of EU-MDR requirements for medical devices. Using a PDCA approach can help you establish an effective process. May 19, 2025Share this postLet's Talk Risk!Quick Tip: Apply the PDCA approach to your clinical evaluation processCopy linkFacebookEmailNotesMore1ShareWatch the full podcast here 👇LTR 83: Road to market for AI devices in the EU just got more complexJan 15Read full storyIf you liked this post, subscribe to Let’s Talk Risk!SubscribePreviousNext
Just to de-mystify the process of reporting on clinical evaluations:
P. T. Barnum, or Barnum and Bailey's Circus, said it first:
Before you do anything, you tell the audience what you're going to do.
As you are doing anything, you tell the audience that you are doing it.
After you finish doing anything, you tell the audience that you have done it.
Clinical evaluation is the same:
Before you do anything, you write a plan that tells everyone what you're gong to do.
As you are executing the plan, you write down the what you are dong.
After you finish execution, you write a summary of the test's results.
If P.T. Barnum can do this, I would certainly hope that professionals in product development and quality can do this. It REALLY is no mystery.