Author Description

Medical Devices Law and Regulation Answer Book 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 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 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.