Class 1 devices : Case studies in medical devices design /

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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 direct...

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Autor principal: Ogrodnik, Peter J. (Autor)
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Amsterdam : Academic Press, [2015]
Temas:
Medical instruments and apparatus > Design and construction.
Analytical, Diagnostic and Therapeutic Techniques and Equipment
Investigative Techniques
Equipment Design
Equipment Design > methods
Equipment and Supplies
TECHNOLOGY & ENGINEERING > Technical & Manufacturing Industries & Trades.
Case Reports
Case studies.
�Etudes de cas.
Acceso en línea:Texto completo
Tabla de Contenidos:
  • 1. Introduction
  • 1.1. Reminder concerning classification
  • 1.2. A reminder concerning the importance of design rigour (or design control)
  • 1.3. A reminder concerning understanding the problem
  • 1.4. A reminder concerning a team/holistic approach
  • 1.5. 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
  • 2. Classification
  • 2.1. Introduction
  • 2.1.1. Timing
  • 2.2. FDA classification
  • 2.2.1. Keywords
  • 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
  • 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
  • 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
  • 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)
  • 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
  • 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
  • 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
  • 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
  • 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)
  • 6.5. The final furlong
  • 6.5.1. EU
  • 6.5.2. FDA
  • 6.6. Continual improvement.

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