Managing medical devices within a regulatory framework /

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Otros Autores: Fiedler, Beth Ann
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Amsterdam : Elsevier, 2016, �2017.
Temas:
Medical instruments and apparatus > Management.
M�edecine > Appareils et instruments > Gestion.
HEALTH & FITNESS > Holism.
HEALTH & FITNESS > Reference.
MEDICAL > Alternative Medicine.
MEDICAL > Atlases.
MEDICAL > Essays.
MEDICAL > Family & General Practice.
MEDICAL > Holistic Medicine.
MEDICAL > Osteopathy.
Acceso en línea:Texto completo
Tabla de Contenidos:
  • Front Cover; Managing Medical Devices within a Regulatory Framework; Related titles; Managing Medical Devices within a Regulatory Framework; Copyright; Dedication; Contents; List of Contributors; Foreword; Preface; 1
  • Medical Device Development and Regulatory Overview; 1
  • Reframing Product Life Cycle for Medical Devices; 1.1 INTRODUCTION; 1.2 FDA TOTAL PRODUCT LIFE CYCLE; 1.2.1 CONCEPTION; 1.2.2 PROTOTYPE; 1.2.3 PRECLINICAL INVESTIGATION; 1.2.4 ADVANCED CLINICAL/POSTMARKETING STUDIES; 1.2.5 END OF LIFE; 1.3 EUROPEAN COMMISSION PRODUCT LIFE CYCLE; 1.4 SUMMARY; DEFINITIONS; REFERENCES.
  • RECOMMENDATIONS FOR ADDITIONAL READING2
  • Overview of Medical Device Clinical Trials; 2.1 INTRODUCTION; 2.2 MEDICAL DEVICE SUBMISSIONS OVERVIEW; 2.3 MEDICAL DEVICE CLINICAL TRIALS; 2.3.1 INVESTIGATIONAL DEVICE EXEMPTION; 2.3.2 CLINICAL TRIALS; 2.3.3 MANUFACTURING AND ADDITIONAL STANDARDS; 2.4 REGULATORY PROFILE OF THE US MEDICAL DEVICE BY CLASSIFICATION TYPE; 2.4.1 CLASS I MEDICAL DEVICES; 2.4.2 CLASS II MEDICAL DEVICES; 2.4.3 CLASS III MEDICAL DEVICES; 2.5 REGULATORY PROFILE OF THE EU MEDICAL DEVICE BY CLASSIFICATION TYPE; 2.6 SUMMARY; DEFINITIONS; REFERENCES.
  • RECOMMENDATIONS FOR ADDITIONAL READING3
  • Review Regulatory Guidelines by Device Classification Type; 3.1 INTRODUCTION; 3.2 BASIC OVERVIEW OF THE PREMARKET NOTIFICATION 510(K); 3.2.1 TYPES OF 510(K); 3.2.2 PRIMARY 510(K) SUBMISSION STEPS; 3.2.3 SUBSTANTIAL EQUIVALENCE; 3.3 PREMARKET APPROVAL APPLICATION REGULATORY PATH; 3.3.1 PMA TYPES; 3.3.2 PRESUBMISSION INTERACTION; 3.3.3 PMA FOOD AND DRUG ADMINISTRATION REVIEWS; 3.3.4 PRE-INVESTIGATIONAL DEVICE EXEMPTION SUBMISSION; 3.4 Medical Device Class I; 3.5 MEDICAL DEVICE CLASS II; 3.6 MEDICAL DEVICE CLASS III.
  • 3.6.1 CLINICAL EVALUATION AND IDE SUBMISSION3.7 SUMMARY; DEFINITIONS; REFERENCES; RECOMMENDATIONS FOR ADDITIONAL READING; 4
  • Manufacturing/Distribution Considerations; 4.1 INTRODUCTION; 4.2 US PRECLINICAL STAGE; 4.2.1 PRODUCT LIFE CYCLE MANAGEMENT; 4.2.2 CURRENT GOOD MANUFACTURING PRACTICES; 4.3 US POSTMARKET STAGE; 4.3.1 ADVERSE EVENT MEDICAL DEVICE REPORTING; 4.3.2 POSTMARKETING 522 STUDIES; 4.3.3 REIMBURSEMENT; 4.4 EUROPEAN UNION CE MARKING: PREMARKETING STAGE; 4.4.1 CE MARKING; 4.4.2 NOTIFIED BODY BEST PRACTICES; 4.5 EU POSTMARKET STAGE; 4.5.1 ADVERSE EVENT MEDICAL DEVICE REPORTING.
  • 4.5.2 POSTMARKETING STUDIES4.5.3 REIMBURSEMENT; 4.6 SUMMARY; DEFINITIONS; REFERENCES; RECOMMENDATIONS FOR ADDITIONAL READING; 2
  • Defining and Meeting Regulatory Challenges in Clinical Engineering; 5
  • Defining and Meeting Regulatory Challenges in Clinical Engineering; 5.1 INTRODUCTION; 5.2 BIOCOMPATIBILITY; 5.2.1 ISO AND OTHER RESOURCE GUIDANCE; 5.2.2 CROSS-FUNCTIONAL KNOWLEDGE BASE REPOSITORIES; 5.2.2.1 The Front End of Medical Device Development in the Product Life Cycle; 5.2.2.2 The Back End of Medical Device Development in the Product Life Cycle.

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