Medical Device Design and Regulation

The intent of this book (MDDR, for short) is to present an introduction to, and overview of, the world of medical device regulation by the United States Food and Drug Administration (FDA), and the relationship of this regulatory scheme to the design and development of medical devices. In providing this information, the book covers the broad range of requirements, which are presented within eight major topics: background and regulatory environment, device design control, nonclinical testing, clinical testing, marketing applications, post-market requirements, quality systems/GMPs, and compliance/enforcement. This book provides students and professionals in the medical device industry with a road map to the regulation of medical devices. It provides a broad understanding of the breadth and depth of medical device regulation by collecting in one textbook coverage of the regulatory scheme for medical devices in terms that are suitable for engineers, scientists, and healthcare providers. The vast amount of information available on the subject is distilled into a concise and coherent presentation. There also are problems and projects at the end of each chapter. Content: Front Matter • List of Figures and Tables • List of Abbreviations • Introduction • Table of Contents 1. Background and Regulatory Environment 2. Medical Device Design 3. Nonclinical Testing and GLPs 4. Clinical Trials 5. Marketing Applications 6. Post-Market Requirements 7. Quality Systems and GMPs 8. Compliance and Enforcement Appendices Index The intent of this book (MDDR, for short) is to present an introduction to, and overview of, the world of medical device regulation by the United States Food and Drug Administration (FDA), and the relationship of this regulatory scheme to the design and development of medical devices. In providing this information, the book covers the broad range of requirements, which are presented within eight major topics: background and regulatory environment, device design control, nonclinical testing, clinical testing, marketing applications, post-market requirements, quality systems/GMPs, and compliance/enforcement. This book provides students and professionals in the medical device industry with a road map to the regulation of medical devices. It provides a broad understanding of the breadth and depth of medical device regulation by collecting in one textbook coverage of the regulatory scheme for medical devices in terms that are suitable for engineers, scientists, and healthcare providers. The vast amount of information available on the subject is distilled into a concise and coherent presentation. There also are problems and projects at the end of each chapter. In addition to the usual questions requiring specific answers, the projects include the drafting of a device control plan, the development of a nonclinical test procedure, the resolution of a recall, the response to a Warning Letter, and the creation of a CAPA for a device deficiency. A solutions manual for these exercises is available to teachers who adopt the textbook for classroom use or for employee training. Medical Device Design and Regulation (MDDR) also makes available over 100 complimentary live hyperlinks to web pages with additional relevant information, and offers users the opportunity to join and participate in the “MDDR Users Group” on LinkedIn. The intent of this book (MDDR, for short) is to present an introduction to, and overview of, the world of medical device regulation by the United States Food and Drug Administration (FDA), and the relationship of this regulatory scheme to the design and development of medical devices. In providing this information, the book covers the broad range of requirements, which are presented within eight major topics: background and regulatory environment, device design control, nonclinical testing, clinical testing, marketing applications, post-market requirements, quality systems/GMPs, and compliance/enforcement. This book provides students and professionals in the medical device industry with a road map to the regulation of medical devices. It provides a broad understanding of the breadth and depth of medical device regulation by collecting in one textbook coverage of the regulatory scheme for medical devices in terms that are suitable for engineers, scientists, and healthcare providers. The vast amount of information available on the subject is distilled into a concise and coherent presentation.

There also are problems and projects at the end of each chapter. In addition to the usual questions requiring specific answers, the projects include the drafting of a device control plan, the development of a nonclinical test procedure, the resolution of a recall, the response to a Warning Letter, and the creation of a CAPA for a device deficiency. A solutions manual for these exercises is available to teachers who adopt the textbook for classroom use. Medical Device Design and Regulation (MDDR) also makes available over 100 complimentary live hyperlinks to web pages with additional relevant information, and offers users the opportunity to join and participate in the “MDDR Users Group” on LinkedIn.

Sponsored by the Construction Institute of ASCE.

This Manual of Practice covers major issues related to the analysis and design of composite joints and frame connections manufactured from fiber-reinforced polymer (FRP) composites in general and pultruded (PFRP) composites in particular.

Topics include:
• design philosophy and design considerations for structural composite members and connections;
• basic information and research and development work on the mechanics of fasteners and bolted composite joints;
• analysis and design methods for bolted composite joints;
• basic physical and mechanical information on structural adhesives and bonded composite joints;
• analysis and design methods for bonded composite joints;
• structural performance combined (bolted/bonded) joints;
• basic information and research and development related to PFRP framing connections;
• analysis and design methods for PFRP framing connections; and
• numerical analysis review of available finite element codes suitable for modeling and designing composite frame structures.

MOP 102 addresses issues that are lacking in other national and international standards, design manuals, and technical publications. It will be valuable to structural engineers designing with FRP or PFRP composites

Sponsored by the Construction Institute of ASCE. This Manual of Practice covers major issues related to the analysis and design of composite joints and frame connections manufactured from fiber-reinforced polymer (FRP) composites in general and pultruded (PFRP) composites in particular. Topics include: design philosophy and design considerations for structural composite members and connections; basic information and research and development work on the mechanics of fasteners and bolted composite joints; analysis and design methods for bolted composite joints; basic physical and mechanical information on structural adhesives and bonded composite joints; analysis and design methods for bonded composite joints; structural performance combined (bolted/bonded) joints; basic information and research and development related to PFRP framing connections; analysis and design methods for PFRP framing connections; and numerical analysis review of available finite element codes suitable for modeling and designing composite frame structures. MOP 102 addresses issues that are lacking in other national and international standards, design manuals, and technical publications. It will be valuable to structural engineers designing with FRP or PFRP composites MOP 102 covers major issues related to the analysis and design of composite joints and frame connections manufactured from fiber-reinforced polymer (FRP) composites in general and pultruded (PFRP) composites in particular. Examines issues related to the analysis and design of composite joints and frame connections manufactured from fibre-reinforced polymer (FRP) composites in general and pultruded (PFRP) composites in particular.