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Class 1 devices : case studies in medical devices design / / Peter J. Ogrodnik
| Class 1 devices : case studies in medical devices design / / Peter J. Ogrodnik |
| Autore | Ogrodnik Peter J. |
| Edizione | [1st edition] |
| Pubbl/distr/stampa | London, [England] ; ; San Diego, California : , : Academic Press, , 2015 |
| Descrizione fisica | 1 online resource (115 p.) |
| Disciplina | 681.761 |
| Soggetto topico | Medical instruments and apparatus - Design and construction |
| ISBN | 0-12-800796-6 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Cover; Title Page; Copyright Page; Dedication; Contents; Acknowledgements; Chapter 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; Case Study: The OTC Joint Support; Case Study: Surgical Wire Cutters; Case Study: Orthopaedic Cast; 1.6.1 - Comments Concerning the Case Studies
1.7 - Hints to enable you to understand the textChapter 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; Chapter 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 Chapter 4 - Conceptual Phase4.1 - 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; Chapter 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 Verification5.2.2.5 - 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; Chapter 6 - The Home Run; 6.1 - A summary of activity; 6.2 - The technical file 6.3 - A note about manufacturing6.4 - A note about post market surveillance (PMS); 6.5 - The final furlong; 6.5.1 - EU; 6.5.2 - FDA; 6.6 - Continual improvement; References; I - Essential Requirements; I - General requirements; II - Requirements regarding design and construction |
| Record Nr. | UNINA-9910787907803321 |
Ogrodnik Peter J.
|
||
| London, [England] ; ; San Diego, California : , : Academic Press, , 2015 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Class 1 devices : case studies in medical devices design / / Peter J. Ogrodnik
| Class 1 devices : case studies in medical devices design / / Peter J. Ogrodnik |
| Autore | Ogrodnik Peter J. |
| Edizione | [1st edition] |
| Pubbl/distr/stampa | London, [England] ; ; San Diego, California : , : Academic Press, , 2015 |
| Descrizione fisica | 1 online resource (115 p.) |
| Disciplina | 681.761 |
| Soggetto topico | Medical instruments and apparatus - Design and construction |
| ISBN | 0-12-800796-6 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Cover; Title Page; Copyright Page; Dedication; Contents; Acknowledgements; Chapter 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; Case Study: The OTC Joint Support; Case Study: Surgical Wire Cutters; Case Study: Orthopaedic Cast; 1.6.1 - Comments Concerning the Case Studies
1.7 - Hints to enable you to understand the textChapter 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; Chapter 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 Chapter 4 - Conceptual Phase4.1 - 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; Chapter 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 Verification5.2.2.5 - 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; Chapter 6 - The Home Run; 6.1 - A summary of activity; 6.2 - The technical file 6.3 - A note about manufacturing6.4 - A note about post market surveillance (PMS); 6.5 - The final furlong; 6.5.1 - EU; 6.5.2 - FDA; 6.6 - Continual improvement; References; I - Essential Requirements; I - General requirements; II - Requirements regarding design and construction |
| Record Nr. | UNINA-9910824254203321 |
|
Ogrodnik Peter J.
|
||
| London, [England] ; ; San Diego, California : , : Academic Press, , 2015 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||