A simple guide to understanding medical device regulations /Shalinee Naidoo.

Includes bibliographies and index.

Chapter 1 Introduction -- Chapter 2 What is a Medical Device? -- Chapter 3 Classification of Medical Devices -- 3.1. Factors Influencing Device Classification Schemes -- 3.2. Initial Classification Rules As Defined By The Global Harmonization Task Force -- 3.3. Eu Guidelines On Medical Device Classification -- 3.4. Understanding How To Apply The Rules Of Medical Device Classification

3.5. How To Apply The Eu Medical Device Classification Rules -- 3.6. Understanding The Rules Governing Guidelines For The Classification Of Medical Devices According To Meddev 2.4/1 -- Chapter 4 History of Medical Device Regulations -- Chapter 5 Understanding the 2001 Model Regulatory Program for Medical Devices as Laid Out By WHO -- 5.1. Understanding Section I: Guiding Principles And Essential Features Of A Regulatory Program For Medical Devices -- 5.2. Understanding Section Ii: A Modular Approach To A Regulatory Program For Medical Devices

5.3. Understanding Section Iii: Reuse of Medical Devices -- Chapter 6 Safety of Medical Devices -- 6.1. How Do We Ensure Safety of Medical Devices? -- 6.2. Safety In Relation To Performance Of A Medical Device -- Chapter 7 Assessing The Effectiveness/Performance Of Medical Devices -- 7.1. Participants In Ensuring The Safety of Medical Devices -- 7.2. Understanding The Role Of Each Participant -- 7.3. Shared Responsibilities For Safety And Performance of Medical Devices -- Chapter 8 Conformity Assessments of Medical Devices -- 8.1. Quality Management System (QMS)

8.2. System For Post-Market Surveillance -- 8.3. Technical Documentation -- 8.4. Declaration Of Conformity -- 8.5. Registration Of Manufacturers And Their Medical Devices by The Regulatory Authority -- Chapter 9 Understanding Sted (Summary Technical Documentation) -- 9.1. What Is The Purpose Of Sted? -- 9.2. The Use Of Sted In The Premarket Phase -- 9.3. The Use Of The Sted In The Post-Market Phase -- 9.4. Contents Of Sted -- Chapter 10 Standards -- 10.1. What Are Standards? -- 10.2. Types Of Standard Specifications -- 10.3. The Purpose Of Standards -- 10.4. Types Of Standards

10.5. Development Process Of Standards -- 10.6. Key Principles In The Development Of Iso Standards (As Defined By ISO) -- 10.7. Conformity Assessment With Standards -- 10.8. National And International Standard Systems -- 10.9. Identification Of Standards -- 10.10. The Use Of Standards In Medical Device Regulations -- Chapter 11 The Global Harmonized Task Force -- Chapter 12 Nomenclature Of Medical Devices -- 12.1. The Global Medical Devices Nomenclature System -- 12.2. Development Of GMDN -- 12.3. Understanding The Purpose Of GMDN -- 12.4. Compilation Of The Initial GMDN Nomenclature Database -- 12.5. Understanding The Structure Of The Global Medical Device Nomenclature System.

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