This book offers comprehensive, easy to understand guidance for medical device technology innovators on how to work through the United States Food and Drug Administration (US FDA) regulatory review and approval/grant/clearance process, while also providing insight on the various intellectual property concerns that many medical device innovators face. In the first portion of this book, readers are introduced to important concepts concerning FDA compliance for medical devices, as well as str...

This book provides a comprehensive guide to procuring, utilizing and monetizing intellectual property rights, tailored for readers in the high-tech consumer electronics and software industries, as well as technology startups. Numerous, real examples, case studies and scenarios are incorporated throughout the book to illustrate the topics discussed. Readers will learn what to consider throughout the various creative phases of a product’s lifespan from initial research and development initia...

This book offers a comprehensive, easy to understand guide for startup entities and developing companies, providing insight on the various sources of funding that are available, how these funding sources are useful at each stage of a company’s development, and offers a comprehensive intellectual property strategy that parallels each stage of development. The IP strategies offered in this book take into consideration the goals that most startups and companies have at each stage of developme...

This book offers comprehensive, easy to understand guidance for medical device technology innovators on how to work through the United States FDA regulatory review process, while also providing insight on the various intellectual property concerns that many medical device innovators face. In the first portion of this book, readers are introduced to important concepts concerning FDA compliance for medical devices, as well as strategies for successfully navigating the FDA regulatory review p...

In this fully revised and expanded fourth edition of the essential reference for clinical research coordinators, Deborrah Norris provides expanded coverage of CRC duties and regulatory requirements, including new sections on investigator responsibilities, data clarification, and adverse event reporting. The books five appendices include a directory of CRC resources, updated forms and checklists, state regulatory requirements and contact information, conversion charts and tables, and a glos...

“This extremely useful title is written for anyone planning to implement clinical trials at an institution. … the author has carefully detailed the types of forms, study records, and case report forms. … A powerful appendix and glossary of relevant terms help make this a needed book for any clinical trials office.”— Journal of Hospital LibrarianshipIn this fully revised and expanded fifth edition of the essential reference for clinical research coordinators, Deborr...

Cobert's Manual of Drug Safety and Pharmacovigilance, Fourth Edition, is an updated how-to manual of guiding principles and concepts for those working in the fields of drug safety, clinical research, pharmacology, regulatory affairs, risk management, quality/compliance, and in government and legal professions.This comprehensive and practical guide discusses the theory and the practicalities of drug safety and pharmacovigilance, and provides essential information on drug safety and ...

Combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products. According to the US Food and Drug Administration (FDA), “a combination product is one composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device and a biological product.” Examples include prefilled syringes, pen injectors, autoinjectors, inhalers, transdermal delivery systems, drug-eluting stent...

This book provides a comprehensive overview of how to strategically manage the movement and storage of products or materials from any point in the manufacturing process to customer fulfillment. Topics covered include important tools for strategic decision making, transport, packaging, warehousing, retailing, customer services and future trends. - An introduction to logistics - Provides practical applications - Discusses trends and new strategies in major parts of the logistic industry

Due to the digitization of medical records, more and more health data is readily available. This dynamic has created many opportunities to unlock this information and use it to improve medical practice, and through research and surveillance understand the effectiveness and side effects of drugs and medical devices to ultimately improve the public’s health. This data can also be used for commercial purposes such as sales and marketing. However, this newfound utility raises some profound que...

This book is meant to be a guide to all who want to learn about a highly regulated industry. My approach is to give you, the reader, an example of a fictitious device, and we will take it from a conceptual idea all the way to launch and beyond. My intention is to incorporate the best experiences that I and other contributors have had into this book and convert them into laymans terms for those who are in need. These experiences can and will be indispensable to beginners and professionals a...

The ASQ Certified Medical Device Auditor Handbook (formerly The Biomedical Quality Auditor Handbook) was developed by the ASQ Medical Device Division (formerly Biomedical Division) in support of its mission to promote the awareness and use of quality principles, concepts, and technologies in the medical device community. It principally serves as a resource to candidates preparing for the Certified Medical Device Auditor (CMDA) certification exam. The fourth edition of this handbook has bee...