| |
|
|
|
|
|
|
|
|
1. |
Record Nr. |
UNINA9910462130303321 |
|
|
Autore |
Ogrodnik Peter J |
|
|
Titolo |
Medical device design [[electronic resource] ] : innovation from concept to market / / Peter J. Ogrodnik |
|
|
|
|
|
|
|
Pubbl/distr/stampa |
|
|
Boston, : Academic Press, 2013 |
|
|
|
|
|
|
|
ISBN |
|
1-283-75437-1 |
0-12-391943-6 |
|
|
|
|
|
|
|
|
Edizione |
[1st ed.] |
|
|
|
|
|
Descrizione fisica |
|
1 online resource (369 p.) |
|
|
|
|
|
|
Disciplina |
|
|
|
|
|
|
|
|
Soggetti |
|
Biomedical engineering |
Engineering design |
Electronic books. |
|
|
|
|
|
|
|
|
Lingua di pubblicazione |
|
|
|
|
|
|
Formato |
Materiale a stampa |
|
|
|
|
|
Livello bibliografico |
Monografia |
|
|
|
|
|
Note generali |
|
Description based upon print version of record. |
|
|
|
|
|
|
Nota di bibliografia |
|
Includes bibliographical references and index. |
|
|
|
|
|
|
Nota di contenuto |
|
Front Cover; Medical Device Design; Copyright Page; Contents; Preface; Acknowledgements; 1 Introduction; 1.1 What Is Design?; 1.2 The Design Life Cycle; 1.3 Medical Devices Definitions; 1.4 Summary; References; 2 Classifying Medical Devices; 2.1 Introduction: Why Classify?; 2.2 Classification Rules; 2.3 Classification Case Study; 2.3.1 EU Classification; 2.3.2 USA Classification; 2.3.3 Special Cases; 2.4 Classification Models; 2.5 Classification and the Design Process; 2.6 Summary; References; 3 The Design Process; 3.1 Design Process versus Design Control; 3.2 Design Models |
3.2.1 Pahl and Beitz, and Pugh3.2.2 Divergent-Convergent Model; 3.3 Managing Design; 3.3.1 Common Design Management Models; 3.3.1.1 Serial Design; 3.3.1.2 Ad Hoc Feedback; 3.3.1.3 Concurrent Design/Concurrent Engineering; 3.3.1.4 Collaborative Models; 3.3.1.5 Holistic Models; 3.3.1.6 Which Model Is Best for Me?; 3.4 Cross-Reference with Regulatory Requirements; 3.5 Summary; Tasks; References; Further Reading; 4 Implementing Design Procedures; 4.1 Introduction; 4.2 Review of Guidelines; 4.3 Overall Procedure; 4.4 Audit /Review Procedure; 4.5 The Design Process; 4.5.1 New Product Procedure |
|
|
|
|
|
|
|
|
|
|
|
4.5.2 Clarification/Product Specification Procedure4.5.3 Detailed Design Procedure; 4.5.4 Design Verification/Validation/Evaluation Procedure; 4.5.5 Design Changes; 4.5.6 Control of Documents; 4.5.7 Risk Assessment Procedure; 4.6 Implementing a Procedure; 4.7 Summary; References; 5 Developing Your Product Design Specification; 5.1 Introduction; 5.2 Developing the Statement of Need (or Brief); 5.2.1 Identifying the "One Thing"; 5.2.2 Formalizing the Statement of Need; 5.3 The Product Design Specification (PDS); 5.3.1 Essential Elements of a PDS; 5.3.1.1 Customer |
5.3.1.2 Regulatory and Statutory5.3.1.3 Technical; 5.3.1.4 Performance; 5.3.1.4.1 Biomechanics; 5.3.1.5 Sales; 5.3.1.6 Manufacturing; 5.3.1.7 Packaging and Transportation; 5.3.1.8 Environmental; 5.3.1.9 Summary; 5.4 Finding, Extracting, and Analyzing the Content; 5.4.1 Focus Groups; 5.4.2 Regulatory Bodies; 5.4.3 Immersion; 5.4.4 Libraries; 5.4.4.1 Standards; 5.4.4.2 Journals and Learned Publications; 5.4.4.3 Books; 5.4.4.4 Librarians; 5.4.5 Technical Literature; 5.4.5.1 General Trade Magazines; 5.4.5.2 Catalogs, Fliers, and Trade Literature; 5.4.6 The Internet; 5.4.7 Conferences and Symposia |
5.4.8 Others5.5 Summary; References; 6 Generating Ideas and Concepts; 6.1 Introduction; 6.2 The "Engineer's Notebook"; 6.3 Creative Space; 6.3.1 The White Room; 6.3.2 Personal Space; 6.4 Generating Concepts/Ideas; 6.4.1 Radial Thinking; 6.4.2 Inversion (or Word Association); 6.4.3 Analogue; 6.4.4 Brainstorming; 6.4.5 Discretizing; 6.4.6 Morphological Analysis; 6.4.7 Research; 6.4.8 We Have Ideas!; 6.5 Selecting Concepts and Ideas; 6.5.1 Morphological Analysis; 6.5.2 Criteria Assessment; 6.5.3 Weighted Criteria Assessment; 6.6 Summary; References; 7 Quality in Design; 7.1 Introduction |
7.2 Optimization |
|
|
|
|
|
|
Sommario/riassunto |
|
This book provides the bridge between engineering design and medical device development. There is no single text that addresses the plethora of design issues a medical devices designer meets when developing new products or improving older ones. It addresses medical devices' regulatory (FDA and EU) requirements--some of the most stringent engineering requirements globally. Engineers failing to meet these requirements can cause serious harm to users as well as their products' commercial prospects. This Handbook shows the essential methodologies medical designers must understand to ensure thei |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2. |
Record Nr. |
UNINA9911011819803321 |
|
|
Autore |
Karabegović Isak |
|
|
Titolo |
New Technologies, Development and Application VIII : Volume 2 / / edited by Isak Karabegović, Ahmed Kovačević, Sadko Mandžuka |
|
|
|
|
|
|
|
Pubbl/distr/stampa |
|
|
Cham : , : Springer Nature Switzerland : , : Imprint : Springer, , 2025 |
|
|
|
|
|
|
|
ISBN |
|
|
|
|
|
|
Edizione |
[1st ed. 2025.] |
|
|
|
|
|
Descrizione fisica |
|
1 online resource (376 pages) |
|
|
|
|
|
|
Collana |
|
Lecture Notes in Networks and Systems, , 2367-3389 ; ; 1483 |
|
|
|
|
|
|
Altri autori (Persone) |
|
KovačevićAhmed |
MandžukaSadko |
|
|
|
|
|
|
|
|
Disciplina |
|
|
|
|
|
|
Soggetti |
|
Computational intelligence |
Engineering mathematics |
Engineering - Data processing |
Computational Intelligence |
Mathematical and Computational Engineering Applications |
|
|
|
|
|
|
|
|
Lingua di pubblicazione |
|
|
|
|
|
|
Formato |
Materiale a stampa |
|
|
|
|
|
Livello bibliografico |
Monografia |
|
|
|
|
|
Sommario/riassunto |
|
This book provides a comprehensive overview of the latest technological achievements, their development and practical applications in various industries. In a world that is constantly changing, technology is the driving force behind progress. This book contains papers focusing on the implementation of new and future technologies, which were presented at the International Conference on New Technologies, Development and Application—Advanced Manufacturing Processes and Intelligent Systems, held at the Academy of Sciences and Arts of Bosnia and Herzegovina in Sarajevo from 26 to 28 June 2025. Through clear and concise analyses, the authors explore key innovations such as robotics, artificial intelligence, internet of things, blockchain, biotechnology and sustainable solutions. Furthermore, new business methods are emerging that are transforming production systems, transportation, delivery and consumption, which every company involved in the global market should monitor and implement. The book offers in-depth insight into how these technologies are transforming business, education, health |
|
|
|
|
|
|
|
|
|
|
care and everyday life. Whether you're a professional looking to stay up to date with the latest trends, a student exploring future career opportunities, or an enthusiast interested in technological change, this book provides useful information and practical, real-world examples. Don't let the future surprise you—find out how new technologies are shaping the world and how you can apply them today. |
|
|
|
|
|
| |