خرید و دانلود نسخه کامل کتاب Medical Device Approval and Regulation in 16 Countries Brief Overviews (Medical Procedures, Testing and Technology)

This book describes the approval process for medical devices in the
European Union and fifteen countries, and also indicates whether or not an
expedited approval procedure is available. Many of the countries reference EU
law, including France, Germany, the Netherlands, and Switzerland. Israel
more readily approves devices with a CE mark (indicating approval in the EU)
or an indication that they are approved by the US Food and Drug
Administration (FDA). In many nations, particularly those influenced by the
EU, part of the review process is conducted not by the government but by
private, independent organizations called “notified bodies.” Furthermore, this
book provides a description of FDA’s medical device review process divided
into two parts: premarket requirements and postmarket requirements.