A simple guide to understanding medical device regulations:
Cover -- Title Page -- Copyright -- ABOUT THE AUTHOR -- TABLE OF CONTENTS -- Glossary -- List of Figures -- List of Tables -- List of Boxes -- List of Abbreviations -- Preface -- Chapter 1 Introduction -- Chapter 2 What is a Medical Device? -- Chapter 3 Classification of Medical Devices -- 3.1. Fact...
Gespeichert in:
| 1. Verfasser: | |
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| Format: | Elektronisch E-Book |
| Sprache: | English |
| Veröffentlicht: |
Burlington, Kanada
Arcler Press
2021
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| Schlagworte: | |
| Online-Zugang: | FHN01 https://ebookcentral.proquest.com/lib/kxp/detail.action?docID=6434672 |
| Zusammenfassung: | Cover -- Title Page -- Copyright -- ABOUT THE AUTHOR -- TABLE OF CONTENTS -- Glossary -- List of Figures -- List of Tables -- List of Boxes -- List of Abbreviations -- Preface -- 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 |
| Beschreibung: | Description based on publisher supplied metadata and other sources |
| Beschreibung: | 1 Online-Ressource (xxiv, 243 Seiten) |
| ISBN: | 9781774078235 |
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| spelling | Naidoo, Shalinee Verfasser (DE-588)1191789632 aut A simple guide to understanding medical device regulations Shalinee Naidoo Burlington, Kanada Arcler Press 2021 1 Online-Ressource (xxiv, 243 Seiten) txt rdacontent c rdamedia cr rdacarrier Description based on publisher supplied metadata and other sources Cover -- Title Page -- Copyright -- ABOUT THE AUTHOR -- TABLE OF CONTENTS -- Glossary -- List of Figures -- List of Tables -- List of Boxes -- List of Abbreviations -- Preface -- 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 Electronic books Erscheint auch als Druck-Ausgabe, Hardcover 978-1-77407-628-6 X:EBC https://ebookcentral.proquest.com/lib/kxp/detail.action?docID=6434672 Aggregator |
| spellingShingle | Naidoo, Shalinee A simple guide to understanding medical device regulations |
| title | A simple guide to understanding medical device regulations |
| title_auth | A simple guide to understanding medical device regulations |
| title_exact_search | A simple guide to understanding medical device regulations |
| title_exact_search_txtP | A simple guide to understanding medical device regulations |
| title_full | A simple guide to understanding medical device regulations Shalinee Naidoo |
| title_fullStr | A simple guide to understanding medical device regulations Shalinee Naidoo |
| title_full_unstemmed | A simple guide to understanding medical device regulations Shalinee Naidoo |
| title_short | A simple guide to understanding medical device regulations |
| title_sort | a simple guide to understanding medical device regulations |
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