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Medical Device Design
Innovation from Concept to Market
Taschenbuch von Peter J. Ogrodnik
Sprache: Englisch

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Beschreibung
Provides a reference to standards and regulations that have been updated, including ISO 13485:2016, FDA regulations and the European Medical Device Regulation Includes new case studies in the areas of classifying medical devices, the design process, quality, labeling, instructions for use, and more Presents additional content around software and biocompatibility concerns
Provides a reference to standards and regulations that have been updated, including ISO 13485:2016, FDA regulations and the European Medical Device Regulation Includes new case studies in the areas of classifying medical devices, the design process, quality, labeling, instructions for use, and more Presents additional content around software and biocompatibility concerns
Über den Autor
Professor Ogrodnik is a Chartered Mechanical Engineer, a Member of the Institution of Engineering Designers and a Fellow (regional) of the Royal Society of Medicine, an Honorary Consultant at the Royal Stoke University Hospital. For over 20 years he has conducted research into optimising the treatment of tibial fractures. Using this research base he has enhanced the application of engineering design principles to the solution of medical devices, his book Medical Devices Design is a core text in core R&D departments.

He has founded two medical devices companies (one manufactures and sells medical devices to the NHS and beyond) and is named inventor on numerous patents. He was a founding director of the University spinout Intelligent Orthopaedics Ltd, and is a founding partner of Metaphysis LLP. Through this corporate involvement Professor Ogrodnik has an understanding of the realities of applied research for industry; for example he was a member of the AWM Healthcare Technologies cluster opportunity group.
Inhaltsverzeichnis

1. Introduction2. Classifying Medical Devices3. The Design Process4. Implementing Design Procedures5. Developing Your Product Design Specification6. Generating Ideas and Concepts7. Enhancing Quality in Design8. Design Realisation/Detailed Design9. Risk Management, Risk Analysis and ISO 1497110. Evaluation (Validation and Verification)11. Manufacturing Supply Chain12. Labelling and Instructions for Use13. Post Market Surveillance14. Protecting Your IP15. Obtaining Regulatory Approval to Market

Appendix A. Useful WebsitesAppendix B. TablesAppendix C. ISO 14971 Annex C Pre-Risk Analysis QuestionnaireAppendix D. Generic Codes for Class I Medical Devices (MHRA)Appendix E. Basic Materials Properties for Materials SelectionAppendix F. Standard Materials in Medicak Devices

Details
Erscheinungsjahr: 2019
Fachbereich: Allgemeine Lexika
Genre: Medizin
Rubrik: Wissenschaften
Medium: Taschenbuch
Inhalt: Kartoniert / Broschiert
ISBN-13: 9780128149621
ISBN-10: 0128149620
Sprache: Englisch
Einband: Kartoniert / Broschiert
Autor: Ogrodnik, Peter J.
Hersteller: Elsevier Science Publishing Co Inc
Maße: 236 x 193 x 32 mm
Von/Mit: Peter J. Ogrodnik
Erscheinungsdatum: 26.10.2019
Gewicht: 0,92 kg
Artikel-ID: 126890178
Über den Autor
Professor Ogrodnik is a Chartered Mechanical Engineer, a Member of the Institution of Engineering Designers and a Fellow (regional) of the Royal Society of Medicine, an Honorary Consultant at the Royal Stoke University Hospital. For over 20 years he has conducted research into optimising the treatment of tibial fractures. Using this research base he has enhanced the application of engineering design principles to the solution of medical devices, his book Medical Devices Design is a core text in core R&D departments.

He has founded two medical devices companies (one manufactures and sells medical devices to the NHS and beyond) and is named inventor on numerous patents. He was a founding director of the University spinout Intelligent Orthopaedics Ltd, and is a founding partner of Metaphysis LLP. Through this corporate involvement Professor Ogrodnik has an understanding of the realities of applied research for industry; for example he was a member of the AWM Healthcare Technologies cluster opportunity group.
Inhaltsverzeichnis

1. Introduction2. Classifying Medical Devices3. The Design Process4. Implementing Design Procedures5. Developing Your Product Design Specification6. Generating Ideas and Concepts7. Enhancing Quality in Design8. Design Realisation/Detailed Design9. Risk Management, Risk Analysis and ISO 1497110. Evaluation (Validation and Verification)11. Manufacturing Supply Chain12. Labelling and Instructions for Use13. Post Market Surveillance14. Protecting Your IP15. Obtaining Regulatory Approval to Market

Appendix A. Useful WebsitesAppendix B. TablesAppendix C. ISO 14971 Annex C Pre-Risk Analysis QuestionnaireAppendix D. Generic Codes for Class I Medical Devices (MHRA)Appendix E. Basic Materials Properties for Materials SelectionAppendix F. Standard Materials in Medicak Devices

Details
Erscheinungsjahr: 2019
Fachbereich: Allgemeine Lexika
Genre: Medizin
Rubrik: Wissenschaften
Medium: Taschenbuch
Inhalt: Kartoniert / Broschiert
ISBN-13: 9780128149621
ISBN-10: 0128149620
Sprache: Englisch
Einband: Kartoniert / Broschiert
Autor: Ogrodnik, Peter J.
Hersteller: Elsevier Science Publishing Co Inc
Maße: 236 x 193 x 32 mm
Von/Mit: Peter J. Ogrodnik
Erscheinungsdatum: 26.10.2019
Gewicht: 0,92 kg
Artikel-ID: 126890178
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