Final Test for Post-Market Surveillance Summary Report Training for Compliance with the ‘New’ SOR/2020-262

Welcome to the final Test. The ‘final’ is a little more serious sounding than I intend it to be. However, I don’t want this to be an anxiety-inducing task. Treat this quiz like an auditor would interview you. If you don’t have an immediate answer, can you find it?

I have confidence that everyone who has made it this far will be able to pass the test. It was not designed to be so easy that it provides no value, but it is not explicitly designed to be nearly unpassable. It was designed to promote the learning process. Either you will pass the first try and confirm that you retained and understood the course materials, or you will identify areas for re-review, and you will have a more substantial knowledge base when you try again. Think of this test as something that represents learning and betterment, harsh tests for the sake of harsh tests are just cruel. My goal is simply to make you more knowledgeable or refresh the knowledge that you did have on this topic. The benchmark is, are you better than when you started? Whether it is by a little or by a lot, I want to celebrate all levels of growth.

Once you have successfully passed the quiz, I want you to pat yourself on the back for your achievement. Then I want you to consider what internal policies you may have for 1. Record Control, and 2. Training and Competency. You will receive a downloadable training certificate. Consider what steps you need to take to incorporate the certificate into your Quality Management System.

That certificate will be a record. Medical Device Academy generated it, so unless you’re taking the training as an internal staff member, this means that you now have a record of external origin. You were able to complete the course to reach the final test. This is verification. You passed the quiz to demonstrate your knowledge and understanding of the topic materials. This is the validation of the training effectiveness. The process output was a record of external origin. Treat this record according to your Quality Management System requirements. It will demonstrate objective evidence of attaining or maintaining training and competency requirements as outlined within your quality system.

So, take a deep breath to banish any test anxiety and know that you can do this. I am here to help others grow, not to be a gatekeeper of the medical device industry. I both want, and believe that you can be successful!

The download link provided below is for a .PDF course description for this class. It goes into much more detail regarding the course content and length than the Certificate of Completion does. It is intended that you use both the Course Description and the Certificate of Completion together as a training record because it explains what you learned, how many CEUs it is worth, and how effectiveness is evidenced.

Supplimental Course Description PostMarket Surveillance Summary Report Training for compliance with the ‘NEW’ SOR/2020-262