TY - BOOK AU - Naidoo,Shalinee TI - A simple guide to understanding medical device regulations /Shalinee Naidoo SN - 9781774078235 AV - K3611 .S567 2021 KW - Medical instruments and apparatus KW - Safety regulations KW - Electronic Books N1 - 2; 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; 2; b UR - httpss://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&db=nlabk&AN=2713644&site=eds-live&custid=s3260518 ER -