Declaration Of Conformity
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The CE Mark
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
Handbook of Medical Device Design
The Handbook of Medical Device Design provides a review of regulatory and standards issues in medical device design, including FDA regulations, types of 510 (k), the ISO 9000 series, and medical device directives. It identifies how to determine and document customer needs and device requirements. It also establishes reliability and quality metrics for the duration of the product development cycle. Topics include
The EU Artificial Intelligence (AI) Act
Author: Ceyhun Necati Pehlivan
language: en
Publisher: Kluwer Law International B.V.
Release Date: 2024-12-03
The EU Artificial Intelligence (AI) Act: A Commentary Edited by Ceyhun Necati Pehlivan, Nikolaus Forgó & Peggy Valcke As artificial intelligence (AI) systems increasingly permeate various facets of our lives, there are growing concerns about their disruptive effects on society and the risks they pose to human rights, democracy, and the rule of law. Accordingly, the AI phenomenon has given rise to numerous governance frameworks at all levels of jurisdiction. In this context, it cannot be denied that the European Union’s AI Act is the first legislation of its kind with global impact, establishing horizontal rules for the development, market placement, and use of AI systems. However, grasping its subtleties and intricacies poses a formidable challenge. This, then, is the first book to offer a reference guide and research tool, providing the full text of the AI Act as published in the Official Journal of 12 July 2024, along with an in-depth, article-by-article commentary. The commentary examines each article in sequential order, ensuring a thorough understanding of every provision. More than eighty prestigious scholars and top-tier professionals, all experts in the field, collectively contribute an exhaustive exploration and analysis of the AI Act, making this volume ‘the’ guide, likely shaping the Act’s interpretation and application in courts, and establishing it as a preeminent resource for legal determinations and academic research. The authors include senior scholars, legal practitioners, judges, and regulators from top law schools, international law firms, and EU institutions. Their authoritative and respected opinions and diverse insights and perspectives will help to shape legal and regulatory frameworks for AI, not only in Europe but worldwide. Lawyers, judges, and other legal professionals will benefit from the book’s lucid interpretation of the AI Act, aiding in its application and compliance, thus enhancing their ability to effectively practice and uphold AI-related regulations. Professionals working in, interested in, and willing to learn more about the field of AI will find thorough guidance, making it an essential resource for anyone involved in AI development and systems design. In addition, policymakers and institutions across the globe will have the opportunity to learn from the EU's pioneering approach, helping them craft their own AI policies and legislation.