Preclinical Testing 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 Preclinical Testing issue of Medical Device Primer covers the functions and stages of preclinical testing; FDA recommended tests; consensus standards; biocompatibility & ISO 10993; conducting preclinical studies; and GLP.