Clinical Trials for Medical Devices

The Medical Device Primer series provides the most efficient means of acquiring the background knowledge necessary to “hit the ground running” as a new engineer, sales/marketing associate, product manager, or supervisor in the medical device industry. Information from leading industry publications, industry insiders, website resources, and textbooks has been streamlined into single, concise, cohesive primers on five different topics. Where space does not allow for complete coverage of a topic, links to the best source available for further information are provided.

The Clinical Trials issue of Medical Device Primer covers the different types of medical device trials; investigational device exemptions (IDEs); study designs; the key elements of an Investigational Plan; running clinical trials including bioresearch monitoring and contract research organizations; and the quality of clinical trials.