Medical Device Training in Malaysia – HRD Corp Claimable Course Scheme

Test Method Validation


The global medical device market is governed by various quality system requirements and regulations of different countries. Medical device manufacturers need to perform test method validation to comply with regulatory requirements and ensure business success



This course provides regulatory/quality systems professionals, manufacturing engineers, and process development engineers with the knowledge and skills needed to comply with the test method validation requirements of the FDA’s Quality System Regulation, EU MDR  2017/745, ISO 13485 and other regulatory requirements on how to implement an effective validation program.


  1. Regulatory/QMS Compliance

1.1  QSR-21 CFR Part 820

1.2  ISO 13485:2016, ISO 9001:2015

1.3  EU Medical Device Regulation (EU MDR 2017/745)

  1. A Brief Overview to Test Method Validation

2.1. Test Method Validation System

  1. Test Method Validation Master Plan

3.1 Overall validation program description

3.2 Life cycle approach

3.3 Risk assessment


  1. Introduction to Test Method Validation

4.1. Overall Validation Program Description

4.2. Validation Definition

4.3. Types of Validation

4.3.1. Prospective Validation/ Concurrent Validation

4.3.2 Retrospective Validation/Revalidation

  1. Test Method Validation Essential Characteristics

5.1. Accuracy

5.2. Precision

5.3. Specificity

5.4. Limit of Detection

5.5. Limit of Quantification

5.6. Linearity

5.7. Range

5.8. Robustness


  1. Elements of Test Method Validation/Software Validation

6.1. User Requirements Specification

6.2. Functional Requirements Specification

6.3. Design Specification

6.4. Installation Qualification (IQ)

6.5. Operational Qualification (OQ)

6.6. Performance Qualification (PQ)

6.7. Maintaining State of Validation

6.8. Deviation in Test Method Validation

6.9. Change Control in Test Method Validation

  1. Statistical Tools & Techniques

7.1. Gage Repeatability and Reproducibility

7.2. Measurement System Analysis

7.3. The 7 Basic QC Tools

7.4. Process Capability Analysis

7.5. Statistical Method and Data Analysis

  1. Test Method Validation- Benefits and Good Documentation Practice

8.1. Good Validation Documentation Practice

8.2. Benefits of Test Method Validation

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