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When it comes to producing, marketing, and shipping medical devices within or into the European Union, ignorance isn't bliss. Keeping current and well versed on CE Mark requirements, though, can be a challenge. The regulations can be technical and difficult to understand. Certain sections apply to certain manufacturer types, but not to others. And deciphering specific requirements can take weeks--even months. In this book, Les Schnoll describes the evolution of the CE Mark and explains its requirements in simple, easy-to-understand terms. He outlines the medical device directives article by article, illustrating which apply to which device and manufacturer type. Inside you'll find chapters about the important role of Notified Bodies in the CE marking process, explanations of the In-Vitro Diagnostic Directive and the Active Implantable Medical Device Directive, a comprehensive glossary, and several charts that plainly demonstrate how to classify device types. Other topics include: The Medical Device Directive articles Medical device classification The Medical Device Directive annexes Essential requirements
This book transcends current debate on government regulation by lucidly outlining how regulations can be a fruitful combination of persuasion and sanctions. The regulation of business by the United States government is often ineffective despite being more adversarial in tone than in other nations. The authors draw on both empirical studies of regulation from around the world and modern game theory to illustrate innovative solutions to this problem. Their ideas include an argument for the empowerment of private and public interest groups in the regulatory process and a provocative discussion of how the government can support and encourage industry self-regulation.
Reeds Nautical Almanac is the indispensable trusted annual compendium of navigational data for yachtsmen and motorboaters, and provides all the information required to navigate Atlantic coastal waters around the whole of the UK, Ireland, Channel Islands and the entire European coastline from the tip of Denmark right down to Gibraltar, Northern Morocco, the Azores and Madeira. The 2021 edition continues the Almanac's tradition of year on year improvement and meticulous presentation of all the data required for safe navigation. Now with an improved layout for easier reference and with over 45,000 annual changes, it is regarded as the bible of almanacs for anyone going to sea. The 2021 edition is updated throughout, containing over 45,000 changes, and includes: 700 harbour chartlets; tide tables and tidal streams; buoyage and lights; 7,500 waypoints; invaluable passage notes; distance tables; radio, weather and safety information; first aid section. Also: a free Marina Guide. Also available: free supplements of up-to-date navigation changes from January to June at: www.reedsnauticalalmanac.co.uk