Medical Devices Law and Regulation Answer Book (2015 Edition)
Author(s): Karen M. Becker, Ph.D., Suzan Onel Practice Area: Health Care, Intellectual Property Date: Aug 2014 i
Previous editions(s) can be found in the Related Items tab.
ISBN: 9781402422607 PLI Item #: 58676
Medical Devices Law and Regulation Answer Book 2015 walks you through the current regulatory requirements and provides in-depth coverage of individual FDA programs that cover everything from conducting clinical trials, preparing successful premarket submissions, adhering to quality system requirements, and fulfilling post-market obligations.
With over thirty contributors from a variety of major law firms and consulting firms specializing in medical device work, Medical Devices Law and Regulation Answer Book 2015 provides practical guidance on how to handle everyday questions on a wide variety of topics, as well as what issues are likely to arise and how to avoid them. The Q&A guide also discusses related topics that have a marked impact on the medical devices industry, such as intellectual property, product liability, and reimbursement.
Medical Devices Law and Regulation Answer Book 2015 is a practical in-depth reference for all lawyers, consultants, and companies operating in the medical devices sector, as well as all companies contemplating entry into the heavily regulated world of medical devices.