The CE Mark

The CE Mark
Author: Les Schnoll
Publisher: Paton Professional
Total Pages: 162
Release: 2007
Genre: Medical
ISBN: 9781932828184

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

Responsive Regulation

Responsive Regulation
Author: Ian Ayres
Publisher: Oxford University Press
Total Pages: 216
Release: 1995-02-16
Genre: Law
ISBN: 0199879958

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 2021

Reeds Nautical Almanac 2021
Author: Perrin Towler
Publisher: Bloomsbury Publishing
Total Pages: 1104
Release: 2020-08-20
Genre: Reference
ISBN: 1472980204

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

Investigating the President

Investigating the President
Author: Douglas L. Kriner
Publisher: Princeton University Press
Total Pages: 301
Release: 2016-08-23
Genre: Political Science
ISBN: 1400883636

Although congressional investigations have provided some of the most dramatic moments in American political history, they have often been dismissed as mere political theater. But these investigations are far more than grandstanding. Investigating the President shows that congressional investigations are a powerful tool for members of Congress to counter presidential aggrandizement. By shining a light on alleged executive wrongdoing, investigations can exert significant pressure on the president and materially affect policy outcomes. Douglas Kriner and Eric Schickler construct the most comprehensive overview of congressional investigative oversight to date, analyzing nearly thirteen thousand days of hearings, spanning more than a century, from 1898 through 2014. The authors examine the forces driving investigative power over time and across chambers, identify how hearings might influence the president's strategic calculations through the erosion of the president’s public approval rating, and uncover the pathways through which investigations have shaped public policy. Put simply, by bringing significant political pressure to bear on the president, investigations often afford Congress a blunt, but effective check on presidential power—without the need to worry about veto threats or other hurdles such as Senate filibusters. In an era of intense partisan polarization and institutional dysfunction, Investigating the President delves into the dynamics of congressional investigations and how Congress leverages this tool to counterbalance presidential power.