Class 1 devices : case studies in medical devices design / / Peter J. Ogrodnik

• Autore: Ogrodnik Peter J.
• Pubblicazione: London, [England] ; ; San Diego, California : , : Academic Press, , 2015; ©2015
• Edizione: 1st edition
• Descrizione fisica: 1 online resource (115 p.)
• Disciplina: 681.761
• Soggetto topico: Medical instruments and apparatus - Design and construction
• Note generali: Description based upon print version of record.
• Nota di bibliografia: Includes bibliographical references.
• 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
• Sommario/riassunto: 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 com
• Titolo autorizzato: Class 1 devices
• ISBN: 0-12-800796-6
• Formato: Materiale a stampa
• Livello bibliografico: Monografia
• Lingua di pubblicazione: Inglese
• Record Nr.: 9910824254203321
• Lo trovi qui: Univ. Federico II