[2021] MEDICAL DEVICE: TEST METHOD VALIDATION

Hello students, in this course you will learn about what a Test Method Validation is.

In this course we have 10 different sections.

In Section 1 we have introduction where we will look at Agenda of course.

Next In section 2 we have measurement system analysis, In this section we will look at what a measurement system is and what a measurement system analysis is and we will look at some of the examples of measurement system analysis and what kind of errors that typically are present in a measurement system and we will also look at accuracy and precision errors and how calibration and test method validation play role in reducing these errors.

Next in In Section 3 we have test method validation introduction, In this section we will look at an introduction to test method validation and prerequisites to authoring a test method validation and also types of test method validation.

Next in section 4, we have visual inspection test methods, in the section we will look at prerequisites for a test method-to-be visual inspection test method and we will also look at what a visual inspection test method is and what a design analysis test method is and what a functional verification test method is and also finally what an industry recognized standard test method is

Next in section 5, we have conventional test methods, in this section we will look at theory of what a conventional test method is and some of the examples.

Next in section 6, we have in-house developed test methods in the section we will also look at theory of what an in-house developed test method is and will also look at some of the examples of this in-house develop test method.

Next in section 7 we have Test method validation, in this section review look at elements of test method validation and we will also look at a general test method validation template that can be used for any type of test method validation development.

Next in Section 8, we have attribute test method validation, in the section we will look at what an attribute test method validation with Theory and also we will look at an example with an attribute test method validation protocol and an attribute test method validation report.

Next in Section 9, we have variable test method validation, in the section we will look at what variable test method validation with Theory and also we will look at an example with a variable test method validation protocol and an attribute test method validation report.

Finally in section 10, we will look at a the conclusion of this test method validation course.

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