International Medical Device Clinical Investigations (A Practical Approach, Second Edition)

The demand for clinical evidence has become an increasingly important issue in the development of medical devices. This demand is reflected not only in regulatory requirements but also by healthcare purchasers as healthcare reforms occur worldwide. Thirteen renowned experts have drawn on their practical experience in industry to provide you with this "recipe" book of how to plan, prepare, implement, and close out a medical device clinical investigation--regardless of where the trial site may be located. While many chapters reference the Medical Device Directive, the principles, philosophies, and methodologies explained are equally applicable to Active Implantable Medical Devices (AIMD) and In-vitro Diagnostic (IVD) products.