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  • What’s New – QMSR Competence Check

The KPI System

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21 CFR 820 QMSR and ISO 13485:2016 – Quiz 1 Master the Essentials.

Validate your knowledge & Master the Essentials of 21CFR 820 QMSR and ISO 13485:2016.
Earn your Certificate of Achievement (your score will be displayed) by demonstrating mastery with a score 85% or higher (click here to see).
For those who below the threshold, a Certificate of Completion (your score will not show) is available to document your participation and effort.

QMSR is in effect starting Feb 2nd. 2026. FDA Inspection methods have changed, and can happen any time. Be prepared – start with these fundamentals now!
Ready for the challenge? Let’s go…

"Quiz / QMSR Competence Assessment: An Introduction to QMSR"
Created by Rai Chowdhary, Lead Auditor (ISO 13485, 9001, and 27001)

Here is how it works 

  • Assessment time: < 10 minutes, and take it as many times as you like; learn for free (Start button provided below).
  • Focus: 21 CFR 820 (QMSR) & ISO 13485 Fundamentals.
  • Outcome: Instant score and personalized gap analysis.

If you would like a certificate signed by the Lead Auditor - please provide your information below (fees required for certificate - see below). Your information will not be sold or shared unless required by law. Or, you can skip and proceed to the Start button.

Your email address (required if you want a certificate with Lead Auditor feedback, fees apply):

Your name (required if you want a certificate):

Phone (required if you want a certificate):

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This quiz must be completed in 6 minutes.
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"Quiz / QMSR Competence Assessment: An Introduction to QMSR"
Created by Rai Chowdhary, Lead Auditor (ISO 13485, 9001, and 27001)

Here is how it works 

  • Assessment time: < 10 minutes, and take it as many times as you like; learn for free (Start button provided below).
  • Focus: 21 CFR 820 (QMSR) & ISO 13485 Fundamentals.
  • Outcome: Instant score and personalized gap analysis.
 
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Get your score instantly for free
Lead Auditor feedback and signed certified certificates are available for $19.95 (Limited time offer).

Created by Rai Chowdhary, Lead Auditor: ISO 13485, 9001, 27001

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Illustration of Certificate - QMSR and ISO 13485 Essentials

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