Advanced Medical Device Development: Test Method Validation
4.3 (41 ratings)
Course Ratings are calculated from individual students’ ratings and a variety of other signals, like age of rating and reliability, to ensure that they reflect course quality fairly and accurately.
4,036 students enrolled

Advanced Medical Device Development: Test Method Validation

TMV
4.3 (41 ratings)
Course Ratings are calculated from individual students’ ratings and a variety of other signals, like age of rating and reliability, to ensure that they reflect course quality fairly and accurately.
4,036 students enrolled
Created by Magine Solutions
Last updated 2/2020
English
English [Auto]
Current price: $37.99 Original price: $54.99 Discount: 31% off
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This course includes
  • 2 hours on-demand video
  • 3 articles
  • 1 downloadable resource
  • Full lifetime access
  • Access on mobile and TV
  • Certificate of Completion
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What you'll learn
  • Attribute and Variable Test Method Validation with Examples
  • Measurement System Analysis
  • Measurement System Analysis Errors
  • Test Method Validation Protocol
  • Test Method Validation Report
  • Minitab Gage R and R Analysis
  • Attribute Agreement Analysis
Requirements
  • None
Description

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.


Music credit: bensound

Who this course is for:
  • The ideal student for this course is anyone who wants to get into a healthcare industry or an existing medical device or pharmaceutical engineering professional who wants to expand on their current skills. There are no requirements necessary to enroll. I only ask to come open-minded and ready to learn.
Course content
Expand all 30 lectures 02:15:06
+ Measurement System Analysis
8 lectures 29:45
MSA Errors: Accuracy (Bias, Linearity & Stability)
04:59
MSA Errors
1 question
Measurement System Analysis: Precision (Repeatability and Reproducibility)
03:23
Mean and Median
05:04
Range Standard Deviation and Variance
04:56
Quantifying MSA Errors: Calibration and Test Method Validation
02:13
+ Test Method Validation: Introduction
3 lectures 09:14
Introduction to TMV - Attribute and Variable Measurement Definitions
04:27
Pre-Requisites to authoring Test Method Validation
02:05
Test Method Validation: Types
02:42
+ Visual Inspection Test Methods
5 lectures 14:09
Pre-requisites for a TM to be Inspection TM
01:32
Visual Inspection TMs Pre-Requisites and Examples
02:58
Design Analysis Test Method Pre-Requisites and Examples
04:39
Functional Verification Test Method Pre-requisites and Examples
02:24
Industry Recognized Standard Test Method and Examples
02:36
+ Conventional Test Methods
1 lecture 02:02
Conventional Test Methods and Examples
02:02
+ In-House Developed Test Methods
1 lecture 01:54
In-house developed test methods and Example
01:54
+ Test Method Validation
1 lecture 07:00
Elements of Test Method Validation
07:00
+ Attribute Test Method Validation
5 lectures 40:00
Attribute Test Method Validation Theory
11:40
Test Method Validation Template
05:31
Attribute Test Method Validation Protocol With an Example
10:15
Attribute Test Method Validation Report
12:25
Practice Attribute Test Method Validaiton Example
00:09
+ Variable Test Method Validation
4 lectures 27:26
Variable Test Method Validation Theory
09:55
Variable Test Method Validation Protocol with an Example
11:25
Variable Test Method Validation Report with an Example
05:50
Practice Destructive Variable Test Method Validation Example.
00:16