rdf-syntax-grammar
mods:
  schema location: http://www.loc.gov/mods/v3 http://www.loc.gov/standards/mods/v3/mods-3-2.xsd
  title info:
    title: Managing medical devices within a regulatory framework
  name:
    name part: Fiedler, Beth Ann.
  name:
    name part: Knovel (Firm)
  type of resource: text
  genre: Electronic books.
  origin info:
    place:
      place term: ne
    place:
      place term: Amsterdam
    publisher: Elsevier
    date issued: 2016, ©2017
    date issued: 2016
    copyright date: 2016
    issuance: monographic
  language:
    language term: eng
  physical description:
    form: remote
    extent: 1 online resource (382)
  table of contents: 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.
  table of contents: 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.
  table of contents: 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.
  table of contents: 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.
  table of contents: 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.
  note: edited by Beth Ann Fielder.
  subject:
    topic: Medical instruments and apparatus
    topic: Management
  subject:
    topic: Médecine
    topic: Appareils et instruments
    topic: Gestion
  subject:
    topic: HEALTH & FITNESS
    topic: Holism
  subject:
    topic: HEALTH & FITNESS
    topic: Reference
  subject:
    topic: MEDICAL
    topic: Alternative Medicine
  subject:
    topic: MEDICAL
    topic: Atlases
  subject:
    topic: MEDICAL
    topic: Essays
  subject:
    topic: MEDICAL
    topic: Family & General Practice
  subject:
    topic: MEDICAL
    topic: Holistic Medicine
  subject:
    topic: MEDICAL
    topic: Osteopathy
  classification: R856
  classification: 610.28/4
  related item:
    title info:
      title: Managing medical devices within a regulatory framework
    origin info:
      publisher: Amsterdam : Elsevier, 2016, ©2017
    identifier: (OCoLC)949750139
  identifier: 9780128041925
  identifier: 0128041927
  identifier: 9780128041796
  identifier: 012804179X
  identifier: 953816 MIL
  identifier: http://proxy.library.tamu.edu/login
  record info:
    record content source: IDEBK
    record creation date: 160916
    record change date: 20230110224054.5
    record identifier: in00004638077
    language of cataloging:
      language term: eng