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The Resource Class 1 devices : Case studies in medical devices design, Peter J. Ogrodnik

Class 1 devices : Case studies in medical devices design, Peter J. Ogrodnik

Label
Class 1 devices : Case studies in medical devices design
Title
Class 1 devices
Title remainder
Case studies in medical devices design
Statement of responsibility
Peter J. Ogrodnik
Title variation
Case studies in medical devices design
Creator
Author
Subject
Language
eng
Summary
The Case Studies in Medical Devices Design series consists of practical, applied case studies relating to medical device design in industry. These titles complement Ogrodnik's Medical Device Design and will assist engineers with applying the theory in practice. The case studies presented directly relate to Class I, Class IIa, Class IIb and Class III medical devices. Designers and companies who wish to extend their knowledge in a specific discipline related to their respective class of operation will find any or all of these titles a great addition to their library. Class 1 Devices is a companion text to Medical Devices Design: Innovation from Concept to Market. The intention of this book, and its sister books in the series, is to support the concepts presented in Medical Devices Design through case studies. In the context of this book the case studies consider Class I (EU) and 510(k) exempt (FDA) . This book covers classifications, the conceptual and embodiment phase, plus design from idea to PDS
Cataloging source
N$T
Illustrations
illustrations
Index
no index present
Literary form
non fiction
Nature of contents
  • dictionaries
  • bibliography
Class 1 devices : Case studies in medical devices design, Peter J. Ogrodnik
Label
Class 1 devices : Case studies in medical devices design, Peter J. Ogrodnik
Link
http://libproxy.rpi.edu/login?url=http://www.sciencedirect.com/science/book/9780128000281
Publication
Copyright
Related Contributor
Related Location
Related Agents
Related Authorities
Related Subjects
Antecedent source
unknown
Bibliography note
Includes bibliographical references
Carrier category
online resource
Carrier category code
cr
Carrier MARC source
rdacarrier
Color
multicolored
Content category
text
Content type code
txt
Content type MARC source
rdacontent
Contents
  • 1.4.
  • 5.3.2.2.
  • Transition from FMEA to Risk Analysis (RA)
  • 5.3.2.3.
  • Essential Requirements (Especially for EU)
  • 5.3.2.4.
  • Validation, Verification and Clinical Evaluation
  • 5.3.2.5.
  • IFUs, Labelling, Other Instructions and Markings
  • 5.4.
  • Summary
  • A reminder concerning a team/holistic approach
  • 6.
  • The Home Run
  • 6.1.
  • A summary of activity
  • 6.2.
  • The technical file
  • 6.3.
  • A note about manufacturing
  • 6.4.
  • A note about post market surveillance (PMS)
  • 1.5.
  • 6.5.
  • The final furlong
  • 6.5.1.
  • EU
  • 6.5.2.
  • FDA
  • 6.6.
  • Continual improvement
  • A reminder concerning costs
  • 1.6.
  • Introduction to the case studies
  • 1.6.1.
  • Comments Concerning the Case Studies
  • 1.7.
  • Hints to enable you to understand the text
  • 1.
  • 2.
  • Classification
  • 2.1.
  • Introduction
  • 2.1.1.
  • Timing
  • 2.2.
  • FDA classification
  • 2.2.1.
  • Keywords
  • Introduction
  • 2.3.
  • EU MDD classification
  • 2.4.
  • Your turn
  • 3.
  • Taking the Design from Idea to PDS
  • 3.1.
  • Introduction
  • 3.2.
  • Developing the specification
  • 1.1.
  • 3.2.1.
  • The Need
  • 3.2.2.
  • The PDS
  • 3.2.3.
  • Customer Section
  • 3.2.4.
  • Regulatory and Statutory Section
  • 3.2.5.
  • Technical Section and Performance Section
  • Reminder concerning classification
  • 3.2.6.
  • Sales Section
  • 3.2.7.
  • Manufacturing Section
  • 3.2.8.
  • Packaging and Transportation Section
  • 3.2.9.
  • Environmental Section
  • 4.
  • Conceptual Phase
  • 1.2.
  • 4.1.
  • A reminder about space
  • 4.2.
  • The relationship with your product design specification (PDS)
  • 4.3.
  • Solution selection
  • 4.3.1.
  • Initial Screening (optional)
  • 4.3.2.
  • Detailed Selection (Essential)
  • A reminder concerning the importance of design rigour (or design control)
  • 4.4.
  • Summary
  • 5.
  • Embodiment Phase
  • 5.1.
  • A reminder about this phase
  • 5.2.
  • Initial embodiment -- or first prototype phase
  • 5.2.1.
  • Detailed Drawings and Specifications of Components
  • 1.3.
  • 5.2.2.
  • Calculations/Simulations Demonstrating Performance and Quality in Design
  • 5.2.2.1.
  • FMEA
  • 5.2.2.2.
  • Optimisation
  • 5.2.2.3.
  • Design for X
  • 5.2.2.4.
  • Validation and Verification
  • A reminder concerning understanding the problem
  • 5.2.2.5.
  • Design for Manufacture
  • 5.3.
  • Prototype to final design
  • 5.3.1.
  • Link Between this Stage and the Previous Stage
  • 5.3.2.
  • Detailed Drawings and Specifications
  • 5.3.2.1.
  • A Reminder About Logging Modifications
http://library.link/vocab/cover_art
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Dimensions
unknown
http://library.link/vocab/discovery_link
{'f': 'http://opac.lib.rpi.edu/record=b4171146'}
Extent
1 online resource
File format
unknown
Form of item
online
Isbn
9780128000281
Level of compression
unknown
Media category
computer
Media MARC source
rdamedia
Media type code
c
Other physical details
illustrations (some color)
Quality assurance targets
not applicable
Reformatting quality
unknown
Sound
unknown sound
Specific material designation
remote

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      42.729766 -73.682577
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