[Place of publication not identified] : Academic Press, 2012.
Book — 1 online resource : illustrations Digital: data file.
Introduction Classifying medical devices The design process Implementing design procedures Developing your product design specification Generating ideas and concepts Quality in design Design realization/Detailed design Evaluation (validation and verification) Manufacturing supply chain Labeling and instructions for use Postmarket surveilance Protecting your IP Obtaining regulatory approval to market.
(source: Nielsen Book Data)
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 their products meet requirements. It brings together proven design protocols and puts them in an explicit medical context based on the author's years of academia (R&D phase) and industrial (commercialization phase) experience. This design methodology enables engineers and medical device manufacturers to bring new products to the marketplace rapidly. (source: Nielsen Book Data)
Book — 1 online resource (xiii, 224 pages) : illustrations
1 Front Matter--
2 Executive Summary--
2 The Structures and Cultures of the Disciplines: The Common Chemical Bond--
3 Synthesis and Manufacturing: Creating and Exploiting New Substances and New Transformations--
4 Chemical and Physical Transformations--
5 Isolating, Identifying, Imaging, and Measuring Substances and Structures--
6 Chemical Theory and Computer Modeling: From Computational Chemistry to Process Systems Engineering--
7 The Interface with Biology and Medicine--
8 Materials by Design--
9 Atmospheric and Environmental Chemistry--
10 Energy: Providing for the Future--
11 National and Personal Security--
12 How To Achieve These Goals--
15 Appendix A: Biographical Sketches of Steering Committee Members--
16 Appendix B: Statement of Task--
17 Appendix C: Contributors--
(source: Nielsen Book Data)
Chemistry and chemical engineering have changed significantly in the last decade. They have broadened their scopea "into biology, nanotechnology, materials science, computation, and advanced methods of process systems engineering and controla "so much that the programs in most chemistry and chemical engineering departments now barely resemble the classical notion of chemistry. Beyond the Molecular Frontier brings together research, discovery, and invention across the entire spectrum of the chemical sciencesa "from fundamental, molecular-level chemistry to large-scale chemical processing technology. This reflects the way the field has evolved, the synergy at universities between research and education in chemistry and chemical engineering, and the way chemists and chemical engineers work together in industry. The astonishing developments in science and engineering during the 20th century have made it possible to dream of new goals that might previously have been considered unthinkable. This book identifies the key opportunities and challenges for the chemical sciences, from basic research to societal needs and from terrorism defense to environmental protection, and it looks at the ways in which chemists and chemical engineers can work together to contribute to an improved future. (source: Nielsen Book Data)